Publications by authors named "Rajiv Dhand"

72 Publications

Measuring Peak Inspiratory Flow in Patients with Chronic Obstructive Pulmonary Disease.

Int J Chron Obstruct Pulmon Dis 2022 6;17:79-92. Epub 2022 Jan 6.

National Heart and Lung Institute, Imperial College London and Royal Brompton Hospital, London, UK.

Dry powder inhalers (DPIs) are breath actuated, and patients using DPIs need to generate an optimal inspiratory flow during the inhalation maneuver for effective drug delivery to the lungs. However, practical and standardized recommendations for measuring peak inspiratory flow (PIF)-a potential indicator for effective DPI use in chronic obstructive pulmonary disease (COPD)-are lacking. To evaluate recommended PIF assessment approaches, we reviewed the Instructions for Use of the In-Check™ DIAL and the prescribing information for eight DPIs approved for use in the treatment of COPD in the United States. To evaluate applied PIF assessment approaches, we conducted a PubMed search from inception to August 31, 2021, for reports of clinical and real-life studies where PIF was measured using the In-Check™ DIAL or through a DPI in patients with COPD. Evaluation of collective sources, including 47 applicable studies, showed that instructions related to the positioning of the patient with their DPI, instructions for exhalation before the inhalation maneuver, the inhalation maneuver itself, and post-inhalation breath-hold times varied, and in many instances, appeared vague and/or incomplete. We observed considerable variation in how PIF was measured in clinical and real-life studies, underscoring the need for a standardized method of PIF measurement. Standardization of technique will facilitate comparisons among studies. Based on these findings and our clinical and research experience, we propose specific recommendations for PIF measurement to standardize the process and better ensure accurate and reliable PIF values in clinical trials and in daily clinical practice.
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http://dx.doi.org/10.2147/COPD.S319511DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8747625PMC
January 2022

Optimizing high-flow nasal cannula flow settings in adult hypoxemic patients based on peak inspiratory flow during tidal breathing.

Ann Intensive Care 2021 Nov 27;11(1):164. Epub 2021 Nov 27.

Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.

Background: Optimal flow settings during high-flow nasal cannula (HFNC) therapy are unknown. We investigated the optimal flow settings during HFNC therapy based on breathing pattern and tidal inspiratory flows in patients with acute hypoxemic respiratory failure (AHRF).

Methods: We conducted a prospective clinical study in adult hypoxemic patients treated by HFNC with a fraction of inspired oxygen (FO) ≥ 0.4. Patient's peak tidal inspiratory flow (PTIF) was measured and HFNC flows were set to match individual PTIF and then increased by 10 L/min every 5-10 min up to 60 L/min. FO was titrated to maintain pulse oximetry (SpO) of 90-97%. SpO/FO, respiratory rate (RR), ROX index [(SpO/FO)/RR], and patient comfort were recorded after 5-10 min on each setting. We also conducted an in vitro study to explore the relationship between the HFNC flows and the tracheal FO, peak inspiratory and expiratory pressures.

Results: Forty-nine patients aged 58.0 (SD 14.1) years were enrolled. At enrollment, HFNC flow was set at 45 (38, 50) L/min, with an FO at 0.62 (0.16) to obtain an SpO/FO of 160 (40). Mean PTIF was 34 (9) L/min. An increase in HFNC flows up to two times of the individual patient's PTIF, incrementally improved oxygenation but the ROX index plateaued with HFNC flows of 1.34-1.67 times the individual PTIF. In the in vitro study, when the HFNC flow was set higher than PTIF, tracheal peak inspiratory and expiratory pressures increased as HFNC flow increased but the FO did not change.

Conclusion: Mean PTIF values in most patients with AHRF were between 30 and 40 L/min. We observed improvement in oxygenation with HFNC flows set above patient PTIF. Thus, a pragmatic approach to set optimal flows in patients with AHRF would be to initiate HFNC flow at 40 L/min and titrate the flow based on improvement in ROX index and patient tolerance.

Trial Registration: ClinicalTrials.gov (NCT03738345). Registered on November 13th, 2018. https://clinicaltrials.gov/ct2/show/NCT03738345?term=NCT03738345&draw=2&rank=1.
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http://dx.doi.org/10.1186/s13613-021-00949-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8626729PMC
November 2021

Mitigating Fugitive Aerosols during Aerosol Delivery via High-Flow Nasal Cannula Devices.

Respir Care 2021 Nov 17. Epub 2021 Nov 17.

Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, Tennessee, USA.

Aerosol delivery via high-flow nasal cannula (HFNC) has attracted clinical interests in recent years. However, both HFNC and nebulization are categorized as aerosol generating procedures (AGPs). In-vitro studies raised concerns that AGPs had high transmission risk. Very few in-vivo studies examined fugitive aerosols with HFNC and nebulization via HFNC, and effective methods to mitigate aerosol dispersion are unknown. Two HFNC devices (Airvo2 and Vapotherm) with or without a vibrating mesh nebulizer (VMN) were compared; HFNC alone, surgical mask over HFNC interface, and HFNC with face tent scavenger were used in a random order for nine healthy volunteers. Fugitive aerosol concentrations at sizes of 0.3-10 µm were continuously measured by particle sizers placed at one and three feet from participants. On a different day, six of the nine participants received six additional nebulizer treatments via VMN or small volume nebulizer (SVN) with mouthpiece with/without an expiratory filter or facemask. In-vitro simulation was employed to quantify inhaled dose with VMN via Airvo2 and Vapotherm. Compared to baseline, neither HFNC device generated higher aerosol concentrations. Compared to HFNC alone, VMN via Airvo2 generated higher 0.3-1.0 µm particles (all p<.05) but VMN via Vapotherm did not. Concentrations of 1.0-3.0 µm particles with VMN via Airvo2 were similar with VMN and a mouthpiece/facemask but lower than SVN with a mouthpiece/facemask (all p<.05). Placing a surgical mask over HFNC during nebulization reduced 0.5-1.0 µm particles (all p<.05) to levels similar to the use of a nebulizer with mouthpiece and expiratory filter. In-vitro the inhaled dose with VMN via Airvo2 was ≥6 times higher than VMN via Vapotherm. During aerosol delivery via HFNC, Airvo2 generated higher inhaled dose and consequently higher fugitive aerosols than Vapotherm. Simple measures, such as placing a surgical mask over nasal cannula during nebulization via HFNC, could effectively reduce fugitive aerosol concentrations.
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http://dx.doi.org/10.4187/respcare.09589DOI Listing
November 2021

Efficacy of Various Mitigation Devices in Reducing Fugitive Emissions from Nebulizers.

Respir Care 2021 Nov 9. Epub 2021 Nov 9.

Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, IL.

Fugitive aerosol concentrations generated by different nebulizers and interfaces , and mitigation of aerosol dispersion into the environment with various commercially available devices are not known. Nine healthy volunteers were given 3 mL saline with a small volume nebulizer (SVN) or vibrating mesh nebulizer (VMN) with a mouthpiece, a mouthpiece with an exhalation filter, an aerosol mask with open ports for SVN and a valved facemask for VMN, and a facemask with a scavenger (Exhalo) in random order. Five of the participants received treatments using a face tent scavenger (Vapotherm) and a mask with exhalation filter with SVN and VMN in a random order. Treatments were performed in an ICU room, with 2 particle counters positioned 1 and 3 feet from participants measuring aerosol concentrations at sizes of 0.3-10 µm at baseline, before, during and after each treatment. The Ethics Committee at Rush University approved this study. Fugitive aerosol concentrations were higher with SVN than VMN and higher with a facemask than a mouthpiece. Adding an exhalation filter to a mouthpiece reduced aerosol concentrations of 0.3-1.0 µm in size for VMN and 0.3-3.0 µm for SVN (all p<0.05). An Exhalo scavenger over the mask reduced 0.5-3.0 µm sized particle concentrations for SVN (all p<0.05) but not VMN. Vapotherm scavenger and filter facemask reduced fugitive aerosol concentrations regardless of the nebulizer type. SVN produced higher fugitive aerosol concentrations than VMN, while facemasks generated higher aerosol concentrations than mouthpieces. Adding an exhalation filter to the mouthpiece or a scavenger to the facemask reduced aerosol concentrations for both SVN and VMN. Vapotherm scavenger and filter facemask reduced fugitive aerosol as effectively as a mouthpiece with an exhalation filter. This study provides guidance for reducing fugitive aerosol emissions from nebulizers in clinical practice.
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http://dx.doi.org/10.4187/respcare.09546DOI Listing
November 2021

Digital Inhalers for Asthma or Chronic Obstructive Pulmonary Disease: A Scientific Perspective.

Pulm Ther 2021 Dec 11;7(2):345-376. Epub 2021 Aug 11.

Dignity Health Woodland Clinic, 632 W Gibson Rd, Woodland, CA, USA.

Impressive advances in inhalation therapy for patients with asthma and chronic obstructive pulmonary disease (COPD) have occurred in recent years. However, important gaps in care remain, particularly relating to poor adherence to inhaled therapies. Digital inhaler health platforms which incorporate digital inhalers to monitor time and date of dosing are an effective disease and medication management tool, promoting collaborative care between clinicians and patients, and providing more in-depth understanding of actual inhaler use. With advances in technology, nearly all inhalers can be digitalized with add-on or embedded sensors to record and transmit data quantitating inhaler actuations, and some have additional capabilities to evaluate inhaler technique. In addition to providing an objective and readily available measure of adherence, they allow patients to interact with the device directly or through their self-management smartphone application such as via alerts and recording of health status. Clinicians can access these data remotely and during patient encounters, to better inform them about disease status and medication adherence and inhaler technique. The ability for remote patient monitoring is accelerating interest in and the use of these devices in clinical practice and research settings. More than 20 clinical studies of digital inhalers in asthma or COPD collectively show improvement in medication adherence, exacerbation risk, and patient outcomes with digital inhalers. These studies support previous findings about patient inhaler use and behaviors, but with greater granularity, and reveal some new findings about patient medication-taking behaviors. Digital devices that record inspiratory flows with inhaler use can guide proper inhaler technique and may prove to be a clinically useful lung function measure. Adoption of digital inhalers into practice is still early, and additional research is needed to determine patient and clinician acceptability, the appropriate place of these devices in the therapeutic regimen, and their cost effectiveness. Video: Digital Inhalers for Asthma or Chronic Obstructive Pulmonary Disease: A Scientific Perspective (MP4 74535 kb).
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http://dx.doi.org/10.1007/s41030-021-00167-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8589868PMC
December 2021

Aerosol delivery systems for treating obstructive airway diseases during the SARS-CoV-2 pandemic.

Intern Emerg Med 2021 11 30;16(8):2035-2039. Epub 2021 Jul 30.

Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes CoronaVirus Disease 2019 (COVID-19), has resulted in a worldwide pandemic and currently represents a major public health crisis. It has caused outbreaks of illness through person-to-person transmission of the virus mainly via close contacts, and droplets produced by an infected person's cough or sneeze. Aerosolised inhaled therapy is the mainstay for treating obstructive airway diseases at home and in healthcare settings, but there is heightened particular concern about the potential risk for transmission of SARS-CoV-2 in the form of aerosolised respiratory droplets during the nebulised treatment of patients with COVID-19. As a consequence of this concern, the use of hand-held inhalers, especially pressurised metered dose inhalers, has risen considerably as an alternative to nebulisers, and this switch has led to inadequate supplies of inhalers in some countries. However, there is no evidence supporting an increased risk of viral transmission during nebulisation in COVID-19 patients. Furthermore, some patients may be unable to adequately use their new device and may not benefit fully from the switch to treatment via hand-held inhalers. Thus, there is no compelling reason to alter aerosol delivery devices for patients with established nebuliser-based regimens. The purpose of this paper is to discuss the current evidence and understanding of the use of aerosolised inhaled therapies during the SARS-CoV-2 pandemic and to provide some guidance on the measures to be taken to minimise the risk of transmitting infection, if any, during aerosol therapies.
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http://dx.doi.org/10.1007/s11739-021-02812-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323748PMC
November 2021

Correction to: Inhalation Therapy for Stable COPD: 20 Years of GOLD Reports.

Adv Ther 2021 Sep;38(9):4986-4988

Department of Medicine, Graduate School of Medicine, University of Tennessee Medical Center, Knoxville, TN, USA.

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http://dx.doi.org/10.1007/s12325-021-01857-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8587232PMC
September 2021

Why We Should Target Small Airways Disease in Our Management of Chronic Obstructive Pulmonary Disease.

Mayo Clin Proc 2021 09 26;96(9):2448-2463. Epub 2021 Jun 26.

Observational and Pragmatic Research Institute, Singapore; Optimum Patient Care, Cambridge, UK; Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.

For more than 50 years, small airways disease has been considered a key feature of chronic obstructive pulmonary disease (COPD) and a major cause of airway obstruction. Both preventable and treatable, small airways disease has important clinical consequences if left unchecked. Small airways disease is associated with poor spirometry results, increased lung hyperinflation, and poor health status, making the small airways an important treatment target in COPD. The early detection of small airways disease remains the key barrier; if detected early, treatments designed to target small airways may help reduce symptoms and allow patients to maintain their activities. Studies are needed to evaluate the possible role of new drugs and novel drug formulations, inhalers, and inhalation devices for treating small airways disease. These developments will help to improve our management of small airways disease in patients with COPD.
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http://dx.doi.org/10.1016/j.mayocp.2021.03.016DOI Listing
September 2021

Inhaled Treprostinil in Group 3 Pulmonary Hypertension.

N Engl J Med 2021 May;384(19):1869-1870

University of Tennessee Graduate School of Medicine, Knoxville, TN

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http://dx.doi.org/10.1056/NEJMc2103465DOI Listing
May 2021

The Impact of Inhaler Device Regimen in Patients with Asthma or COPD.

J Allergy Clin Immunol Pract 2021 08 24;9(8):3033-3040.e1. Epub 2021 Apr 24.

Graduate School of Medicine, University of Tennessee, Knoxville, TN.

Many inhaler devices with varying handling requirements for optimal use are available for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Patients may be prescribed different device types for reliever and maintenance medications, which may lead to confusion and suboptimal device use. We aimed to understand whether simplifying inhaler regimens by employing a single device type in patients who use multiple devices or prescribing a device with which a patient was already experienced could improve clinical and economic outcomes in asthma and COPD management. A targeted literature search was performed and additional articles were identified through hand searching citations within screened publications. A total of 114 articles were included in the final review. Findings suggest that simplifying inhaler regimens by applying the same type of inhaler for concomitant inhaled medications over time minimizes device misuse, leading to improved clinical outcomes and reduced health care use in patients with asthma or COPD. Physicians should consider a patient's suitability for a device and training needs when prescribing an inhaled medication and before changing the medication type or dose, especially when suboptimal treatment outcomes are observed. Further research is required to determine whether consistent use of the same device type is associated with better treatment adherence and persistence in patients with asthma or COPD. Nevertheless, this literature review identified clinical benefits and reduced health care use with simplified inhaler regimens.
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http://dx.doi.org/10.1016/j.jaip.2021.04.024DOI Listing
August 2021

Mitigating Viral Dispersion during Respiratory Support Procedures in the ICU.

Authors:
Rajiv Dhand

Am J Respir Crit Care Med 2021 05;203(9):1051-1053

Department of Medicine University of Tennessee Graduate School of Medicine Knoxville, Tennessee.

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http://dx.doi.org/10.1164/rccm.202102-0317EDDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8314900PMC
May 2021

Asthma in Adult Patients with COVID-19. Prevalence and Risk of Severe Disease.

Am J Respir Crit Care Med 2021 04;203(7):893-905

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Graduate School of Medicine, University of Tennessee Medical Center, Knoxville, Tennessee.

Health outcomes of people with coronavirus disease (COVID-19) range from no symptoms to severe illness and death. Asthma, a common chronic lung disease, has been considered likely to increase the severity of COVID-19, although data addressing this hypothesis have been scarce until very recently. To review the epidemiologic literature related to asthma's potential role in COVID-19 severity. Studies were identified through the PubMed (MEDLINE) and medRxiv (preprint) databases using the search terms "asthma," "SARS-CoV-2" (severe acute respiratory syndrome coronavirus 2), and "COVID-19," and by cross-referencing citations in identified studies that were available in print or online before December 22, 2020. Asthma prevalence data were obtained from studies of people with COVID-19 and regional health statistics. We identified 150 studies worldwide that allowed us to compare the prevalence of asthma in patients with COVID-19 by region, disease severity, and mortality. The results of our analyses do not provide clear evidence of increased risk of COVID-19 diagnosis, hospitalization, severity, or mortality due to asthma. These findings could provide some reassurance to people with asthma regarding its potential to increase their risk of severe morbidity from COVID-19.
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http://dx.doi.org/10.1164/rccm.202008-3266OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017581PMC
April 2021

Effects of Inhaled Epoprostenol and Prone Positioning in Intubated Coronavirus Disease 2019 Patients With Refractory Hypoxemia.

Crit Care Explor 2020 Dec 16;2(12):e0307. Epub 2020 Dec 16.

Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN.

Objectives: To evaluate the effects of inhaled epoprostenol and prone positioning, individually and in combination in mechanically ventilated patients with coronavirus disease 2019 and refractory hypoxemia.

Design: Retrospective study.

Setting: Academic hospital adult ICUs.

Patients: Adult patients who received inhaled epoprostenol and prone positioning during invasive ventilation were enrolled. Patients were excluded if inhaled epoprostenol was initiated: 1) at an outside hospital, 2) after prone positioning was terminated, 3) during extracorporeal membrane oxygenation or cardiopulmonary resuscitation, and 4) with Pao/Fio greater than 150 mm Hg.

Interventions: Inhaled epoprostenol and prone positioning.

Results: Of the 43 eligible patients, 22 and seven received prone positioning and inhaled epoprostenol alone, respectively, prior to their use in combination, Pao/Fio was not different pre- and post-prone positioning or inhaled epoprostenol individually (89.1 [30.6] vs 97.6 [30.2] mm Hg; = 0.393) but improved after the combined use of inhaled epoprostenol and prone positioning (84.0 [25.6] vs 124.7 [62.7] mm Hg; < 0.001). While inhaled epoprostenol and prone positioning were instituted simultaneously in 14 patients, Pao/Fio was significantly improved (78.9 [27.0] vs 150.2 [56.2] mm Hg, = 0.005) with the combination. Twenty-seven patients (63%) had greater than 20% improvement in oxygenation with the combination of inhaled epoprostenol and prone positioning, and responders had lower mortality than nonresponders (52 vs 81%; = 0.025).

Conclusions: In critically ill, mechanically ventilated patients with coronavirus disease 2019 who had refractory hypoxemia, oxygenation improved to a greater extent with combined use of inhaled epoprostenol and prone positioning than with each treatment individually. A higher proportion of responders to combined inhaled epoprostenol and prone positioning survived compared with nonresponders. These findings need to be validated by randomized, prospective clinical trials.
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http://dx.doi.org/10.1097/CCE.0000000000000307DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7746203PMC
December 2020

Airborne Particulate Concentrations During and After Pulmonary Function Testing.

Chest 2021 04 1;159(4):1570-1574. Epub 2020 Nov 1.

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN.

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http://dx.doi.org/10.1016/j.chest.2020.10.064DOI Listing
April 2021

A narrative review on trans-nasal pulmonary aerosol delivery.

Crit Care 2020 08 17;24(1):506. Epub 2020 Aug 17.

Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.

The use of trans-nasal pulmonary aerosol delivery via high-flow nasal cannula (HFNC) has expanded in recent years. However, various factors influencing aerosol delivery in this setting have not been precisely defined, and no consensus has emerged regarding the optimal techniques for aerosol delivery with HFNC. Based on a comprehensive literature search, we reviewed studies that assessed trans-nasal pulmonary aerosol delivery with HFNC by in vitro experiments, and in vivo, by radiolabeled, pharmacokinetic and pharmacodynamic studies. In these investigations, the type of nebulizer employed and its placement, carrier gas, the relationship between gas flow and patient's inspiratory flow, aerosol delivery strategies (intermittent unit dose vs continuous administration by infusion pump), and open vs closed mouth breathing influenced aerosol delivery. The objective of this review was to provide rational recommendations for optimizing aerosol delivery with HFNC in various clinical settings.
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http://dx.doi.org/10.1186/s13054-020-03206-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7430014PMC
August 2020

Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: An Interim Guidance Endorsed by the International Society of Aerosols in Medicine.

J Aerosol Med Pulm Drug Deliv 2020 12 12;33(6):300-304. Epub 2020 Aug 12.

Department of Medicine, Graduate School of Medicine, University of Tennessee Health Science Center, Knoxville, Tennessee, USA.

National and international guidelines recommend droplet/airborne transmission and contact precautions for those caring for coronavirus disease 2019 (COVID-19) patients in ambulatory and acute care settings. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, an acute respiratory infectious agent, is primarily transmitted between people through respiratory droplets and contact routes. A recognized key to transmission of COVID-19, and droplet infections generally, is the dispersion of bioaerosols from the patient. Increased risk of transmission has been associated with aerosol generating procedures that include endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, turning the patient to the prone position, disconnecting the patient from the ventilator, noninvasive positive-pressure ventilation, tracheostomy, and cardiopulmonary resuscitation. The knowledge that COVID-19 subjects can be asymptomatic and still shed virus, producing infectious droplets during breathing, suggests that health care workers (HCWs) should assume every patient is potentially infectious during this pandemic. Taking actions to reduce risk of transmission to HCWs is, therefore, a vital consideration for safe delivery of all medical aerosols. Guidelines for use of personal protective equipment (glove, gowns, masks, shield, and/or powered air purifying respiratory) during high-risk procedures are essential and should be considered for use with lower risk procedures such as administration of uncontaminated medical aerosols. Bioaerosols generated by infected patients are a major source of transmission for SARS CoV-2, and other infectious agents. In contrast, therapeutic aerosols do not add to the risk of disease transmission unless contaminated by patients or HCWs.
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http://dx.doi.org/10.1089/jamp.2020.1615DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757542PMC
December 2020

Reproducible Dosing With a Jet Nebulizer During Invasive Mechanical Ventilation.

Authors:
Rajiv Dhand

Respir Care 2020 Aug;65(8):1223-1224

Department of MedicineUniversity of Tennessee Graduate School of MedicineKnoxville, Tennessee.

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http://dx.doi.org/10.4187/respcare.08279DOI Listing
August 2020

Coughs and Sneezes: Their Role in Transmission of Respiratory Viral Infections, Including SARS-CoV-2.

Authors:
Rajiv Dhand Jie Li

Am J Respir Crit Care Med 2020 09;202(5):651-659

Division of Respiratory Care, Department of Cardiopulmonary Sciences, Rush University Medical Center, Chicago, Illinois.

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http://dx.doi.org/10.1164/rccm.202004-1263PPDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462404PMC
September 2020

Maintenance Therapy with Nebulizers in Patients with Stable COPD: Need for Reevaluation.

Pulm Ther 2020 Dec 20;6(2):177-192. Epub 2020 May 20.

Department of Medicine, Graduate School of Medicine, University of Tennessee Medical Center, Knoxville, TN, USA.

Patients with stable COPD rely heavily on inhaled bronchodilators and corticosteroids to control symptoms, maximize quality of life, and avoid exacerbations and costly hospitalizations. These drugs are typically delivered by hand-held inhalers or nebulizers. The majority of patients are prescribed inhalers due to their perceived convenience, portability, and lower cost, relative to nebulizers. Unfortunately, poor inhaler technique compromises symptom relief in most of these patients. In contrast to one or two puffs through an inhaler, nebulizers deliver a drug over many breaths, through tidal breathing, and hence are more forgiving to poor inhalation technique. To what extent susceptibility to errors in their use may influence the relative effectiveness of these two types of inhalation device has received little attention in COPD research. In 2005, a systematic review of the literature concluded that nebulizers and inhalers are equally effective in patients who are adequately trained to use their inhalation device. This conclusion was based on two small clinical trials that only examined objective measures of lung function. Since then, additional studies have found that maintenance therapy administered by nebulizers could improve patients' reported feelings of symptom relief, quality of life, and satisfaction with treatment, compared to therapy administered by inhalers. Because it has been 15 years since the publication of the systematic review, in this article we summarize the results of studies that compared the effectiveness of inhalers with that of nebulizers in patients with stable COPD and discuss their implications for clinical practice and need for future research.
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http://dx.doi.org/10.1007/s41030-020-00120-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7672144PMC
December 2020

Pulmonary Therapy 2020 Update and Podcast: Meet the Journal's Editors-in-Chief.

Pulm Ther 2020 Jun 9;6(1):1-7. Epub 2020 Apr 9.

Department of Medicine, Graduate School of Medicine, University of Tennessee Medical Center, Knoxville, TN, USA.

The Editors-in-Chief of Pulmonary Therapy have prepared podcasts summarizing their current research, recent highlights from the field, and future predictions. Audio-only versions and the transcripts can be downloaded here: https://doi.org/10.6084/m9.figshare.11938863. Following this is a written summary of the journal's recent developments and the transcripts from the podcasts.
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http://dx.doi.org/10.1007/s41030-020-00114-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7144824PMC
June 2020

Inhalation Therapy for Stable COPD: 20 Years of GOLD Reports.

Adv Ther 2020 05 3;37(5):1812-1828. Epub 2020 Apr 3.

Department of Medicine, Graduate School of Medicine, University of Tennessee Medical Center, Knoxville, TN, USA.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) was formed in the late 1990s to spread awareness of chronic obstructive pulmonary disease (COPD) as a major public health problem and facilitate its prevention and treatment. GOLD has since become internationally recognized for the development of evidence-based strategy documents, most notably the annual GOLD Reports, for COPD diagnosis, management, and prevention. The GOLD Reports incorporate the latest evidence and expert consensus to guide the management and prevention of COPD on a global level. Since the first GOLD Report in 2001, profound innovations have taken place regarding inhaler device options, available pharmaceuticals, knowledge regarding effective dosages and potential side effects, and the various combinations of drugs used to relieve symptoms. Concomitantly, an evolution of expert opinion on how best to apply these innovations to the care of patients with COPD has also taken place, an evolution that is nowhere more detailed or definitive than in the 20 years of annual GOLD Reports. We summarize key features and trends in inhalation therapy for stable COPD in these Reports.
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http://dx.doi.org/10.1007/s12325-020-01289-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7467472PMC
May 2020

Inhaled amikacin adjunctive to intravenous standard-of-care antibiotics in mechanically ventilated patients with Gram-negative pneumonia (INHALE): a double-blind, randomised, placebo-controlled, phase 3, superiority trial.

Lancet Infect Dis 2020 03 19;20(3):330-340. Epub 2019 Dec 19.

Intensive Care Unit, Sorbonne University Hospitals, Paris, France.

Background: Treatment of ventilated pneumonia is often unsuccessful, even when patients are treated according to established guidelines. Therefore, we aimed to investigate the efficacy of the combination drug device Amikacin Inhale as an adjunctive therapy to intravenous standard-of-care antibiotics for pneumonia caused by Gram-negative pathogens in intubated and mechanically ventilated patients.

Methods: INHALE was a prospective, double-blind, randomised, placebo-controlled, phase 3 study comprising two trials (INHALE 1 and INHALE 2) done in 153 hospital intensive-care units in 25 countries. Eligible patients were aged 18 years or older; had pneumonia that had been diagnosed by chest radiography and that was documented as being caused by or showing two risk factors for a Gram-negative, multidrug-resistant pathogen; were intubated and mechanically ventilated; had impaired oxygenation within 48 h before screening; and had a modified Clinical Pulmonary Infection Score of at least 6. Patients were stratified by region and disease severity (according to their Acute Physiology and Chronic Health Evaluation [APACHE] II score) and randomly assigned (1:1) via an interactive voice-recognition system to receive 400 mg amikacin (Amikacin Inhale) or saline placebo, both of which were aerosolised, administered every 12 h for 10 days via the same synchronised inhalation system, and given alongside standard-of-care intravenous antibiotics. All patients and all staff involved in administering devices and monitoring outcomes were masked to treatment assignment. The primary endpoint, survival at days 28-32, was analysed in all patients who received at least one dose of study drug, were infected with a Gram-negative pathogen, and had an APACHE II score of at least 10 at diagnosis. Safety analyses were done in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, numbers NCT01799993 and NCT00805168.

Findings: Between April 13, 2013, and April 7, 2017, 807 patients were assessed for eligibility and 725 were randomly assigned to Amikacin Inhale (362 patients) or aerosolised placebo (363 patients). 712 patients received at least one dose of study drug (354 in the Amikacin Inhale group and 358 in the placebo group), although one patient assigned to Amikacin Inhale received placebo in error and was included in the placebo group for safety analyses. 508 patients (255 in the Amikacin Inhale group and 253 in the placebo group) were assessed for the primary endpoint. We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43). Similar proportions of patients in the two treatment groups had a treatment-emergent adverse event (295 [84%] of 353 patients in the Amikacin Inhale group vs 303 [84%] of 359 patients in the placebo group) or a serious treatment-emergent adverse event (101 [29%] patients vs 97 [27%] patients).

Interpretation: Our findings do not support use of inhaled amikacin adjunctive to standard-of-care intravenous therapy in mechanically ventilated patients with Gram-negative pneumonia.

Funding: Bayer AG.
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http://dx.doi.org/10.1016/S1473-3099(19)30574-2DOI Listing
March 2020

The Confusing World of Dry Powder Inhalers: It Is All About Inspiratory Pressures, Not Inspiratory Flow Rates.

J Aerosol Med Pulm Drug Deliv 2020 02 31;33(1):1-11. Epub 2019 Oct 31.

Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, Tennessee.

Dry powder inhalers (DPIs) all have the ability to aerosolize dry powders, but they each offer different operating mechanisms and resistances to inhaled airflow. This variety has resulted in both clinician and patient confusion concerning DPI performance, use, and effectiveness. Particularly, there is a growing misconception that a single peak inspiratory flow rate (PIFR) can determine a patient's ability to use a DPI effectively, regardless of its design or airflow resistance. For this review article, we have sifted through the relevant literature concerning DPIs, inspiratory pressures, and inspiratory flow rates to provide a comprehensive and concise discussion and recommendations for DPI use. We ultimately clarify that the controlling parameter for DPI performance is not the PIFR but the negative pressure generated by the patient's inspiratory effort. A pressure drop ∼≥1 kPa (∼10 cm HO) with any DPI is a reasonable threshold above which a patient should receive an adequate lung dose. Overall, we explore the underlying factors controlling inspiratory pressures, flow rates and dispensing, and dispersion characteristics of the various DPIs to clarify that inspiratory pressures, not flow rates, limit and control a patient's ability to generate sufficient flow for effective DPI use.
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http://dx.doi.org/10.1089/jamp.2019.1556DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7041319PMC
February 2020

Aerosolized Antibiotics for Treatment of Pneumonia in Mechanically Ventilated Subjects.

Respir Care 2019 Aug;64(8):962-979

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Graduate School of Medicine, University of Tennessee Health Sciences Center Knoxville, Knoxville, Tennessee.

Mechanical ventilation is a well-established and commonly employed modality of treatment for critically ill patients in the ICU. Pneumonia is a frequent complication in mechanically ventilated patients. Patients who develop ventilator-associated pneumonia (VAP) incur higher medical costs, have prolonged ICU and hospital stays, and have increased mortality risk. There is growing interest in finding new treatment modalities for this condition because the success rate for treating VAP with systemic antibiotics continues to be < 70%. Accordingly, clinicians are reevaluating the role of aerosolized antibiotics, either as a sole therapy or as adjuncts to systemic antibiotics, in an attempt to improve clinical outcomes in patients with VAP. There are several clinical settings in which aerosolized antibiotics could be used for treating pneumonia, including their use for prevention, as monotherapy, as adjunctive therapy with systemic antibiotics, and for treatment of extensively drug-resistant or pan drug-resistant pathogens. However, aerosolized antibiotics have not been uniformly effective for improving clinical outcomes of patients with VAP, and local and systemic side effects could complicate their use. Moreover, many questions about aerosolized antibiotics, such as optimal formulations and dosage and treatment regimens, remain unanswered and warrant future investigations.
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http://dx.doi.org/10.4187/respcare.07024DOI Listing
August 2019

Improving usability and maintaining performance: human-factor and aerosol-performance studies evaluating the new reusable Respimat inhaler.

Int J Chron Obstruct Pulmon Dis 2019;14:509-523. Epub 2019 Mar 5.

Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein 55216, Germany,

Purpose: The Respimat is a handheld, propellant-free, soft-mist inhaler. Observations by patients and physicians prompted development of an improved second-generation Respimat inhaler. Human-factor studies assessing the usability of the new inhaler and in vitro assessment of aerosol performance are important to demonstrate functionality of the updated inhaler.

Methods: Studies were performed to assess any possible impact of the reusable Respimat inhaler design on aerosol performance (delivered dose [DD] and fine-particle dose [FPD]) and iteratively assess and improve usability of the new design. The tiotropium-olodaterol inhalation solution for Respimat was used as a model. The DD and FPD of the reusable Respimat inhaler (across multiple cartridges) and the disposable Respimat inhaler were determined by laser diffraction and with an alternative Andersen cascade impactor. Usability was measured across three studies involving health care professionals and patients with diagnoses of COPD, asthma, or combined disease (with and without experience with the Respimat inhaler). These studies measured performance of handling tasks and collected subjective feedback directly related to the inhaler's new or altered features, which fed into optimization of the inhaler.

Results: DDs of tiotropium and olodaterol were stable up to 15 cartridges and consistently within the upper and lower limits of the disposable Respimat inhaler. The FPD was also found to be batch-consistent over the cartridges and comparable with the reference. The usability of the reusable Respimat inhaler compared with the disposable inhaler was improved in terms of assembly and daily use. Cartridge exchange was rated as intuitive and easy to very easy.

Conclusion: The new reusable Respimat is a medical inhaler developed with enhanced features that meets health care professionals' and patients' needs. Drug delivery across multiple cartridges is not affected by the design. Compared with the original disposable inhaler, the usability of the reusable inhaler has been improved, and cartridge exchange was rated as easy to perform. The reusable Respimat provides greater convenience for patients vs the disposable inhaler, with reduced environmental impact.
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http://dx.doi.org/10.2147/COPD.S190639DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6407979PMC
July 2019

Results of a Pulmonologist Survey Regarding Knowledge and Practices With Inhalation Devices for COPD.

Respir Care 2018 07 1;63(7):840-848. Epub 2018 May 1.

University of Tennessee, Knoxville, Tennessee.

Background: COPD guidelines advise on inhaled medication use, yet no advice is offered on when to use and which type of patient could benefit from a specific delivery device. We investigated pulmonologists' perception of their knowledge and practices with delivery devices for COPD management.

Methods: An online survey was designed by a steering committee of American Thoracic Society clinicians and scientists and conducted by a national market research firm between January 7 and 29, 2016.

Results: Two hundred and five respondents completed the survey. Nearly 80% of the respondents believed that they were very knowledgeable in COPD management and the use of medications; 68% believed that they were knowledgeable about preventing exacerbations. Ninety-eight percent of the respondents stated that they were at least somewhat knowledgeable about devices. Many respondents (70%) stated that small-volume nebulizers were more effective than dry powder inhalers and pressurized metered-dose inhalers in the management of COPD exacerbations, and 63% believed that these were more effective in severe COPD (modified Medical Research Council dyspnea scale grade 4). Only 54% of the respondents discussed device options with their patients. Physician screening for physical or cognitive impairments that could impact device choices was 53% and 16%, respectively. Seventy percent of the respondents discussed device use, whereas 9% discussed cleaning and storage during a patient's first visit. Few respondents were very knowledgeable in teaching patients how to use devices (43%) and, specifically, how to use (32%) or clean and/or maintain (20%) small-volume nebulizers.

Conclusions: Most respondents were confident in their knowledge about treating COPD. Fewer respondents were confident about the use and maintenance of inhalation devices, and most respondents desired to learn more about inhalation devices.
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http://dx.doi.org/10.4187/respcare.05717DOI Listing
July 2018

Results of a Patient Survey Regarding COPD Knowledge, Treatment Experiences, and Practices With Inhalation Devices.

Respir Care 2018 07 20;63(7):833-839. Epub 2018 Mar 20.

Icahn School of Medicine at Mount Sinai, New York, New York.

Background: Successful inhalation therapy depends on the ability of patients with COPD to properly use devices. We explored subjects' COPD knowledge, including education they receive from health care providers, treatment experiences, and practices with inhalation devices.

Methods: A multiple-choice online survey, developed by a steering committee of American Thoracic Society clinicians and scientists, was administered to subjects with COPD who were sourced from the Harris Poll Online panel.

Results: Of the 254 respondents (mean age 61.8 y; 49% males), most subjects (82%) claimed to understand their disease and available treatments, yet COPD symptoms and causes were well known to only 45% and 44% of subjects, respectively. Forty-three percent of subjects had ever used a pressurized metered-dose inhaler or dry-powder inhaler. Of the 54% of subjects who had ever used a small-volume nebulizer (SVN), 63% considered this device to be easy to use, 55% considered it to be fast-acting, 53% considered it to be convenient, and 38% considered it to be essential for treatment. Among subjects who had ever used them, SVNs were preferred by 54% over other devices. One third of subjects desired more extensive education during office visits; 25% felt the time was insufficient to cover questions, and 15% felt their concerns about COPD treatment(s) were ignored. Subjects believed physicians (32%), nurses (26%), and no single provider (28%) were primarily responsible for training and assessing proper inhalation technique.

Conclusion: The survey showed differences between patients' beliefs and knowledge of COPD; the need for continuous education from health care providers, particularly on inhalation devices; and extensive use of pressurized metered-dose inhalers and dry-powder inhalers despite positive perceptions of SVNs.
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http://dx.doi.org/10.4187/respcare.05715DOI Listing
July 2018

Considerations for Optimal Inhaler Device Selection in Chronic Obstructive Pulmonary Disease.

Cleve Clin J Med 2018 Feb;85(2 Suppl 1):S19-S27

Abington Family Medicine, Jenkintown, PA, USA.

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http://dx.doi.org/10.3949/ccjm.85.s1.04DOI Listing
February 2018

COPD in Primary Care: Key Considerations for Optimized Management: Considerations for Optimal Inhaler Device Selection in Chronic Obstructive Pulmonary Disease.

J Fam Pract 2018 02;67(2 Suppl):S19-S27

Abington Family Medicine, Jenkintown, PA, USA.

Understanding the advantages and limitations of inhaler devices for chronic obstructive pulmonary disease helps clinicians in choosing the proper device for the individual patient's clinical needs and preferences. However, with the wide range of permutations of drug combinations now possible, inhaler selection remains challenging. For all inhaler devices, adequate training for patients on how to use their device is required to achieve optimal therapeutic benefits.
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February 2018

The Rationale and Evidence for Use of Inhaled Antibiotics to Control Pseudomonas aeruginosa Infection in Non-cystic Fibrosis Bronchiectasis.

Authors:
Rajiv Dhand

J Aerosol Med Pulm Drug Deliv 2018 06 27;31(3):121-138. Epub 2017 Oct 27.

Department of Medicine, University of Tennessee Graduate School of Medicine , Knoxville, Tennessee.

Non-cystic fibrosis bronchiectasis (NCFBE) is a chronic inflammatory lung disease characterized by irreversible dilation of the bronchi, symptoms of persistent cough and expectoration, and recurrent infective exacerbations. The prevalence of NCFBE is on the increase in the United States and Europe, but no licensed therapies are currently available for its treatment. Although there are many similarities between NCFBE and cystic fibrosis (CF) in terms of respiratory symptoms, airway microbiology, and disease progression, there are key differences, for example, in response to treatment, suggesting differences in pathogenesis. This review discusses possible reasons underlying differences in response to inhaled antibiotics in people with CF and NCFBE. Pseudomonas aeruginosa infections are associated with the most severe forms of bronchiectasis. Suboptimal levels of antibiotics in the lung increase the mutation frequency of P. aeruginosa and lead to the development of mucoid strains characterized by formation of a protective polysaccharide biofilm. Mucoid strains of P. aeruginosa are associated with a chronic infection stage, requiring long-term antibiotic therapy. Inhaled antibiotics provide targeted delivery to the lung with minimal systemic toxicity and adverse events compared with oral/intravenous routes of administration, and they could be alternative treatment options to help address some of the treatment challenges in the management of severe cases of NCFBE. This review provides an overview of completed and ongoing trials that evaluated inhaled antibiotic therapy for NCFBE. Recently, several investigators conducted phase 3 randomized controlled trials with inhaled aztreonam and ciprofloxacin in patients with NCFBE. While the aztreonam trial results were not associated with significant clinical benefit in NCFBE, initial results reported from the inhaled ciprofloxacin (dry powder for inhalation and liposome-encapsulated/dual-release formulations) trials hold promise. A more targeted approach could identify specific populations of NCFBE patients who benefit from inhaled antibiotics.
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http://dx.doi.org/10.1089/jamp.2017.1415DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5994662PMC
June 2018
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