Publications by authors named "Simone Gambazza"

31 Publications

Complications of prone positioning in patients with COVID-19: A cross-sectional study.

Intensive Crit Care Nurs 2021 Jun 1:103088. Epub 2021 Jun 1.

Healthcare Professions Department, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy. Electronic address:

Objective: To determine the prevalence of complications in patients with COVID-19 undergone prone positioning, focusing on the development of prone-related pressure ulcers.

Methods: Cross-sectional study conducted in the hub COVID-19 centre in Milan (Italy), between March and June 2020. All patients with COVID-19 admitted to intensive care unit on invasive mechanical ventilation and treated with prone positioning were included. Association between prone-related pressure ulcers and selected variables was explored by the means of logistic regression.

Results: A total of 219 proning cycles were performed on 63 patients, aged 57.6 (10.8) and predominantly obese males (66.7%). The main complications recorded were: prone-related pressure ulcers (30.2%), bleeding (25.4%) and medical device displacement (12.7%), even if no unplanned extubation was recorded. The majority of patients (17.5%) experienced bleeding of upper airways. Only 15 prone positioning cycles (6.8%) were interrupted, requiring staff to roll the patient back in the supine position. The likelihood of pressure ulcers development was independently associated with the duration of prone positioning, once adjusting for age, hypoxemic level, and nutritional status (OR 1.9, 95%CI 1.04-3.6).

Conclusion: The use of prone positioning in patients with COVID-19 was a safe and feasible treatment, also in obese patients, who might deserve more surveillance and active prevention by intensive care unit staff.
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http://dx.doi.org/10.1016/j.iccn.2021.103088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166520PMC
June 2021

Facing COVID-19 Pandemic in a Tertiary Hospital in Milan: Prevalence of Burnout in Nursing Staff Working in Sub-Intensive Care Units.

Int J Environ Res Public Health 2021 06 22;18(13). Epub 2021 Jun 22.

Healthcare Professions Department, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122 Milano, Italy.

In early March 2020, Italy became the epicenter of the Coronavirus Disease 2019 (COVID-19) pandemic in Europe. A different organization of hospital units was required to take care of patients affected by acute respiratory failure caused by COVID-19. This study aimed to evaluate the prevalence of burnout in two sub-intensive care units (SICUs) of the COVID-19 hub center of the Lombardia region in Milan (Italy). All nurses and healthcare assistants working in the SICUs during June 2020 were included in the study. Burnout was assessed via the Maslach Burnout Inventory questionnaire. One hundred and five (84%) SICU staff participated in the study. The prevalence of high burnout for nurses and healthcare assistants was 61.9% for emotional exhaustion, 47.6% for depersonalization and 34.3% for personal accomplishment. Depersonalization was significantly more frequent in younger nurses ( = 0.009). Nurses were 4.5 times more likely to have burnout than healthcare assistants. Burnout was a common condition among healthcare workers operating in SICUs during the pandemic. Urgent actions are needed, especially for nurses, as well as preventive strategies for future pandemic scenarios.
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http://dx.doi.org/10.3390/ijerph18136684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295778PMC
June 2021

Pattern of Visits in a Metropolitan Emergency Department in Lombardia (Italy): January 2019-December 2020.

Healthcare (Basel) 2021 Jun 24;9(7). Epub 2021 Jun 24.

Healthcare Professions Department, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122 Milano, Italy.

During the Coronavirus disease 2019 (COVID-19), a general decrease in the presentations to emergency departments (ED) was reported. However, we suspect that there was a lower number but an unchanged pattern of ED visits for urgent conditions in 2020 compared to 2019. This retrospective study assessed the change in the number of presentations in the ED of a tertiary level university hospital in Milano (Lombardia, Italy). Compared to 2019, a significant drop in ED presentations occurred (-46.4%), and we recorded a -15.7% difference in the proportion of patients admitted with white codes. The pattern of hourly presentations to the ED was unchanged, with overcrowding during the working daytime. COVID-19 changed ED flows, likely causing an overall reduction in the number of deferrable conditions. However, the pattern associated with urgent conditions did not change abruptly in 2020.
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http://dx.doi.org/10.3390/healthcare9070791DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8304284PMC
June 2021

Cystic Fibrosis, New Frontier: Exploring the Functional Connectivity of the Brain Default Mode Network. Comment on Elce et al. Impact of Physical Activity on Cognitive Functions: A New Field for Research and Management of Cystic Fibrosis. 2020, , 489.

Diagnostics (Basel) 2021 May 31;11(6). Epub 2021 May 31.

Department of Neuroradiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Miano, Italy.

We read with great interest the paper entitled "Impact of physical activity of cognitive functions: a new field for research and management of Cystic Fibrosis" by Elce et al. [...].
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http://dx.doi.org/10.3390/diagnostics11061001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8227950PMC
May 2021

The Spread of COVID-19 Among 15,000 Physical Therapists in Italy: A Cross-Sectional Study.

Phys Ther 2021 08;101(8)

IRCCS San Camillo Hospital, Laboratory of Rehabilitation Technologies, Venice, Italy.

Objectives: The purpose of this study was to explore the prevalence, personal- and work-related exposures, and signs and symptoms among physical therapists during the first wave of coronavirus disease 2019 (COVID-19) in Italy.

Methods: This cross-sectional, survey-based study collected demographic and exposure data from physical therapists from April to May 2020. All physical therapists working in inpatient and outpatient care in Italy were eligible. A self-administered questionnaire was distributed among all eligible physical therapists to collect (1) demographic characteristics, (2-3) personal- and work-related exposures, and (4) signs and symptoms of COVID-19. Factors associated with a COVID-19-positive nasopharyngeal swab (NPS) were explored through logistic regression models and multivariate methods.

Results: A total of 15,566 respondents completed the survey, with a response rate of 43.3%, achieving high statistical precision (99% CI, 1% type I error). Among physical therapists who received NPS testing, 13.1% (95% CI = 12.1-14.1%) had a positive result, with a peak reached in March 2020 (36%). The top 5 symptoms were fatigue and tiredness (69.1%), loss of smell (64.5%), aches and pains (60.8%), loss of taste (58.3%), and headache (51.1%). No symptoms were reported by 8.9%. Working in a health care institution (odds ratio [OR] = 12.0; 95% CI = 7.8-18.4), being reallocated to a different unit (OR = 1.9; 95% CI = 1.3-2.7), and changing job tasks (OR = 1.6; 95% CI = 1.2-2.3) increased the risk of being COVID-19 positive. In therapists with a confirmed diagnosis of COVID-19, comorbidities were associated with male sex and age older than 51 years.

Conclusion: During the first wave in Italy, almost 1 out of 7 physical therapists tested positive on the COVID-19 NPS test. Considering personal- and work-related exposures, health care organizations should adopt prevention measures and adequate preparedness to prevent high rate of infections during future pandemics.

Impact: This is the largest investigation about the spread of and main risk factors for COVID-19 in the physical therapy field.
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http://dx.doi.org/10.1093/ptj/pzab123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8136025PMC
August 2021

Home physiotherapists assisting follow-up treatment in cystic fibrosis: a multicenter observational study.

Monaldi Arch Chest Dis 2021 Apr 15;91(2). Epub 2021 Apr 15.

Cystic Fibrosis Centre, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan; 3Department of Clinical Sciences and Community Health, Laboratory of Medical Statistics, Epidemiology and Biometry G. A. Maccacaro, University of Milan .

Inhaled therapies are relatively simple and easy to be managed however ineffective use of aerosols when self-administered may occur. We described variation of the number of clinic visits, lung function and number of antibiotic courses performed over 12 months in participants with cystic fibrosis (CF), when supervised or not by physiotherapists (PTs) at home. Participants in 8 Italian CF centers with a prescription of dry-powder antibiotic choose whether to be supervised at home (PT-FU) or not (non-PT-FU), in adjunct to routine clinic visits. PTs assisted participants with their inhaled therapies regimen and reviewed the airway clearance program in use.  Mixed-effect regression models were fitted to evaluate the variation of selected endpoints over time. A total of 163 participants were included.  Lung function declined over time in both groups, at higher extent in the non-PT-FU group at 6 months (-1.8, 95%CI: -4.4 to 0.7 % predicted), without reaching statistical significance, whereas in the PT-FU group only, nearly one visit less was recorded (p=0.027). Regardless the type of supervision adopted, the number of antibiotic courses did not change compared to the previous year. We counted 19/90 (21.1%) drop-out in the PT-FU, double compared to the group followed up at the clinics (p=0.065). Participants under a course of an inhaled antibiotic therapy showed a 1-year decline in lung function, whereas only the group receiving home supervision counted nearly one visit less at the CF center, whose clinical relevance should be further discussed.
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http://dx.doi.org/10.4081/monaldi.2021.1619DOI Listing
April 2021

Remote support by multidisciplinary teams: A crucial means to cope with the psychological impact of the SARS-COV-2 pandemic on patients with cystic fibrosis and inflammatory bowel disease in Lombardia.

Int J Clin Pract 2021 Jul 25;75(7):e14220. Epub 2021 Apr 25.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Cystic Fibrosis Centre, Milano, Italy.

Background: During Coronavirus Disease 2019 (COVID-19) outbreak in Lombardia, people were recommended to avoid visiting emergency departments and attending routine clinic visits. In this context, it was necessary to understand the psychological reactions of patients with chronic diseases. We evaluated the psychological effects on patients with chronic respiratory conditions and inflammatory bowel disease (IBD) through the analysis of their spontaneous contacts with their referral centres.

Methods: Cross-sectional study was conducted from February 23 to April 27, 2020 in patients, or their parents, who contacted their multidisciplinary teams (MDT). E-mails and phone calls directed to the MDT of the centre for cystic fibrosis (CF) in Milano and for paediatric IBD in Bergamo, were categorised according to their contents as information on routine disease management, updates on the patient's health status, COVID-19 news monitoring, empathy towards health professionals, positive feedback and concern of contagion during the emergency.

Results: One thousand eight hundred and sixteen contacts were collected during the study period. In Milano, where the majority of patients were affected by CF, 88.7% contacted health professionals by e-mail, with paediatricians receiving the largest volume of emails and phone calls compared with other professionals (P< .001). Compared with Milano, the centre for IBD in Bergamo recorded more expression of empathy towards health professionals and thanks for their activity in the COVID-19 emergency (52.4% vs 12.7%, P< .001), as well as positive feedback (64.3% vs 2.7%, P = .003).

Conclusion: One of the most important lessons we can learn from COVID-19 is that it is not the trauma itself that can cause psychological consequences but rather the level of balance, or imbalance, between fragility and resources. To feel safe, people need to be able to count on the help of those who represent a bulwark against the threat. This is the role played, even remotely, by health professionals.
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http://dx.doi.org/10.1111/ijcp.14220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8250111PMC
July 2021

Gene expression profile of normal breast tissue and body mass index.

Breast Cancer 2021 Mar 13;28(2):488-495. Epub 2020 Nov 13.

Laboratory of Medical Statistics and Biometry, 'Giulio A. Maccacaro', Department of Clinical Sciences and Community Health, Campus Cascina Rosa, University of Milan, Milan, Italy.

Background: In human breast, adipose tissue represents up to 80% of the total volume and plays a critical role in mammary gland remodeling. Given the emerging role of obesity in breast cancer growth and development, we explored the relationship between body mass index (BMI), as a proxy of woman's obesity status, and the expression in normal breast tissue from healthy women of a selected panel of genes, known to be involved in mammary gland homeostasis.

Methods: Two independent publicly available datasets, composed of 180 specimens of normal breast tissue from reduction mammoplasty were interrogated. Differential gene expression among BMI classes was evaluated by ANOVA, and partial correlation coefficient was used to assay the correlation between genes controlling for BMI.

Results: Despite the differences in microarray platforms and analytical procedures, the two datasets shared a core of 9 genes differentially expressed in BMI classes and significantly correlated with BMI. Four (44%) of these genes belong to the functional class of cytokines and cytokine receptors (IL1R1, IL2RA, IL12A, and IL12RB2). The others belong to the functional class of the epigenetic regulation (MEDAG and SETD7), signal transduction (STAT1), cell adhesion (ITGAV), and enzymatic activity (STS).

Conclusions: Although exploratory, present findings are in agreement with the role of inflammation modulators in the homeostasis of normal breast tissue and the believe that an increase in body adipose tissue may have a potentially dangerous local effect, through the increased expression of inflammation-related genes and the establishment of a low-grade chronic inflammation.
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http://dx.doi.org/10.1007/s12282-020-01183-zDOI Listing
March 2021

Time Length of Negativization and Cycle Threshold Values in 182 Healthcare Workers with Covid-19 in Milan, Italy: An Observational Cohort Study.

Int J Environ Res Public Health 2020 07 23;17(15). Epub 2020 Jul 23.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Virology Unit, 20122 Milan, Italy.

: Coronavirus Disease 2019 (COVID-19) has rapidly spread worldwide, becoming an unprecedented public health emergency. Rapid detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) suspected cases is crucial to control the spread of infection. We aimed to evaluate the time length of negativization from the onset of symptoms in healthcare workers (HCWs) with COVID-19, and to evaluate significant variations in cycle threshold (CT) values and gene positivity (E, RdRP, and N genes) among positive individuals who returned to work. : We retrospectively analyzed a consecutive cohort of 182 SARS-CoV-2-positive HCWs in Milan, from 16 March to 30 April 2020. Nasopharyngeal swabs were tested by RT-PCR. : Asymptomatic HCWs were 17.6% (32/182), and 58 healed at 30 April 2020. The median time length of negativization was 4 weeks (35% of symptomatic versus 40% of asymptomatic HCWs). Four HCWs, healed at 30 April, turned positive within three weeks during controls set up in the work unit. Three-gene positivity had the greatest variability, and increasing CT values from single- to three-gene positivity among all age groups were observed. : Self-isolation longer than two weeks and prolonged follow-up periods for the staff returning to work after COVID-19 could be the most suitable choices to counter the SARS-CoV-2 spread. Further studies are needed to investigate infectiousness profiles among positive individuals.
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http://dx.doi.org/10.3390/ijerph17155313DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7432921PMC
July 2020

Molecular characterization of Mycobacterium abscessus subspecies isolated from patients attending an Italian Cystic Fibrosis Centre.

New Microbiol 2020 Jul 13;43(3):127-132. Epub 2020 Jun 13.

UOS Microbiology and Cystic Fibrosis Microbiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Mycobacterium abscessus (MABS) infection represents significant management challenge in cystic fibrosis (CF) patients. This retrospective study (2005-2016) aims to determine the prevalence of the subspecies of MABS isolated from CF patients, to evaluate the persistence over the years of a single subspecies of MABS and to correlate mutations responsible for macrolides and amikacin resistance with MIC values. We investigated 314 strains (1 isolate/patient/year) isolated from the lower respiratory tract of 51 chronically infected CF patients. Sequencing of rpoB gene was performed to identify the MABS subspecies. The erm(41) gene was sequenced to differentiate the strains with and without inducible macrolide resistance. Regions of 23S and 16S rRNA were sequenced to investigate mutations responsible for constitutive resistance to macrolides and aminoglycosides, respectively. Antibiotic susceptibility, using commercial microdilution plates, was evaluated according to CLSI. M. abscessus subsp. abscessus accounted for 64% of the isolates, bolletii subspecies for 16% and massiliense subspecies for 20%. All the massiliense strains presented truncated erm(41) gene while 12 abscessus strains presented the mutation T28->C in the erm(41) gene, which makes it inactive. The 23S rRNA analysis did not show constitutive resistance to macrolides in any strain. Mutation of the 16S rRNA gene was highlighted in 2 strains out of 314, in agreement with high MIC values. The correct identification at the subspecies level and the molecular analysis of 23S rRNA, 16S rRNA and erm gene is useful to guide the treatment strategy in patients with M. abscessus lung infection.
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July 2020

Adipokines expression and epithelial cell polarity in normal and cancerous breast tissue.

Carcinogenesis 2020 10;41(10):1402-1408

Laboratory of Medical Statistics and Biometry, 'Giulio A. Maccacaro', Department of Clinical Sciences and Community Health, Campus Cascina Rosa, University of Milan, Via Vanzetti, Milan, Italy.

Cell polarity is crucial for the correct structural and functional organization of epithelial tissue. Its disruption can lead to loss of the apicobasal polarity, alteration in the intracellular components, misregulation of the pathways involved in cell proliferation and cancer promotion. Very recent in vitro/in vivo findings demonstrated that obesity-associated alterations in tissue adipokines protein level negatively affect epithelial polarity. We performed an in silico study to investigate whether such alterations also occur in surgical samples. We aimed to explore the relationship among the expression of the genes coding for leptin (LEP), adiponectin (ADIPOQ), adipokine receptors (LEPR, ADIPOR1 and ADIPOR2), and a panel of polarity-associated genes in normal tissue from breast reduction mammoplasty, and a series of paired samples of histologically normal (HN) tissue and invasive cancer. Results indicated that, in normal tissue, the expression of adipokines and their receptors negatively correlated with that of the polarity-associated genes and GGT1, which codes for γ-glutamyl transferase (GGT) enzyme, a marker of cell distress and membrane disruption. This negative correlation progressively decreased in HN and cancerous tissue, and loss of correlation between ADIPOR2 and polarity-associated genes appeared the most noticeable alteration. Given the growing role of obesity in breast cancer etiology and the opposite action of leptin and adiponectin in epithelial tissue remodeling, ADIPOR2 loss could be addressed as a key mechanism leading to an unbalanced leptin stimulatory activity, subsequent cell polarity disruption and eventually tumor initiation, a finding that requires to be confirmed also at the protein level and with in vivo models.
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http://dx.doi.org/10.1093/carcin/bgaa060DOI Listing
October 2020

Body mass index and γ-glutamyl transferase expression in normal and cancerous breast tissue.

Breast Cancer 2020 Sep 20;27(5):850-860. Epub 2020 Mar 20.

Laboratory of Medical Statistics and Biometry, 'Giulio A. Maccacaro', Department of Clinical Sciences and Community Health, University of Milan, Campus Cascina Rosa, Milan, Italy.

Background: Localized to cell membrane, γ-glutamyl transferase (GGT) is a reliable marker for the evaluation of cell distress occurring in several pathological conditions including obesity, metabolic syndrome, and cancer. In particular, high GGT serum levels are associated with breast cancer incidence and progression.

Methods: The tissue expression of GGT1, the gene coding for GGT, was investigated in silico in a large case series of paired samples of breast cancer and adjacent histologically normal (HN) tissue, and in a collection of healthy breast tissues from reduction mammoplasty. The association of GGT1 with patient's body mass index (BMI), and the relationship between GGT1 and a panel of genes involved in apoptosis, IGF-1 signaling, or coding for adipokines and adipokine receptors were also investigated.

Results: GGT1 expression was significantly higher in tumor than in the adjacent HN tissue (P = 0.0002). Unexpectedly, the expression of GGT1 was inversely associated with BMI in normal and HN tissue, whereas no correlation was found in cancerous tissue. In all tissues, GGT1 correlated positively with TP53 and negatively with BCL2 and LEPR, whereas only in normal and HN tissue GGT1 correlated positively with IGF1R. The linear regression model, adjusted for BMI, showed no confounding effect on any correlation, except for the correlation of GGT1 with LEPR in normal tissue from healthy women.

Conclusions: Even if present results provide interesting insights on the still elusive mechanism(s) underlying the association between obesity and epithelial cell proliferation, possibly promoting neoplastic transformation, such relationship deserves further investigation in other independent datasets.
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http://dx.doi.org/10.1007/s12282-020-01080-5DOI Listing
September 2020

Exercise capacity and ventilation inhomogeneity in cystic fibrosis: A cross-sectional study.

Pediatr Pulmonol 2020 02;55(2):394-400

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Cystic Fibrosis Centre, Milan, Italy.

Background: Lung clearance index (LCI ) is a marker of overall lung ventilation inhomogeneity and has proven to be able to detect early peripheral damage in subjects with cystic fibrosis (CF), with greater sensitivity than conventional spirometry. Combining its sensitivity with the output of an incremental exercise testing, we hypothesized that any sign of ventilation inhomogeneity in subjects without severe airflow obstruction and with a normal exercise tolerance could be relevant for the CF team, tracking early lung disease and potential exercise limiting factors.

Methods: Patients with CF in clinical stable conditions were recruited between 2015 and 2017. Available spirometry, nitrogen multiple-breath washout test and symptoms-limited exercise testing performed as parts of patients' annual routine evaluation were considered for this cross-sectional study. To describe the relationship between exercise intensity and ventilation inhomogeneity, a linear regression analysis was performed using backward elimination based on Akaike information criteria.

Results: Seventy-seven patients (38 females) were included. S and LCI were significantly higher in patients with an overall reduced exercise tolerance. Peak work developed during exercise was associated with body mass index (b = 5.25; 95% confidence interval [CI] = 1.53-8.98), forced expiratory volume in 1 second (FEV ; b = 3.71; 95% CI = 1.96-5.46), Pseudomonas aeruginosa chronic infection (b = -8.84; 95% CI = -15.84 to -1.84) but not with LCI .

Conclusion: Exercise capacity and airflow obstruction are associated in this Italian CF cohort. Considering the greater discriminatory power of LCI over FEV and peak work, the Godfrey protocol without gas analysis cannot provide detailed information about lung function or efficiency. However, this incremental protocol without gas exchange measures can still provide the CF team with information about exercise tolerance and disability.
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http://dx.doi.org/10.1002/ppul.24525DOI Listing
February 2020

CPAP after endoscopic procedures as add-on therapy for the treatment of tracheal stenosis: a case series.

Monaldi Arch Chest Dis 2019 Oct 30;89(3). Epub 2019 Oct 30.

First Level Specializing Master in Physiotherapy and Respiratory Rehabilitation, University of Milan.

Tracheal stenosis represents a possible complication in intubated or tracheotomised patients. Tracheal resection is currently the gold standard for the treatment of complex stenosis while granulomas and simple stenosis (e.g., web-like) are often treated by endoscopic procedures, which do not consistently give satisfactory long-term results, due to frequent relapses. Administering continuous positive airway pressure (CPAP) after endoscopic procedures might represent a new add-on option for the treatment of this complication. In this case series are presented two patients with tracheal stenosis showed after the removal of tracheostomy tube, both treated with CPAP. The results were straightforward: CPAP treatment helped to keep stable the tracheal lumen, without adverse effects. No further endoscopic dilations were necessary thereafter, with a likely positive impact on patients' quality of life and on health expenditure.
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http://dx.doi.org/10.4081/monaldi.2019.1121DOI Listing
October 2019

Lung clearance index in subjects with cystic fibrosis in Italy.

Ital J Pediatr 2019 May 2;45(1):56. Epub 2019 May 2.

Azienda Ospedaliero-Universitaria Meyer, Pediatric University Hospital, Viale Pieraccini 24, 50139, Florence, Italy.

The Lung Clearance Index (LCI) is an index derived from washout recordings, able to detect early peripheral airway damage in subjects with cystic fibrosis (CF) with a greater sensitivity than spirometry.LCI is a marker of overall lung ventilation inhomogeneity; in fact, as pulmonary ventilation worsens, the number of tidal breaths and the expiratory volumes required to clear the lungs of a marker gas are increased, as documented by a greater value.In the field of CF, LCI allows indirect investigation of the small airways (< 2 mm) the site where, from a pathophysiologic point of view, the disease begins due to the defect of the CF transmembrane-conductance regulator (CFTR) protein. Infant pulmonary function changes seem to occur before clinically overt symptoms of lower respiratory illness occur.When performing the test, it is important to refer to the American Thoracic Society and European Respiratory Society consensus statements and apply a strict standardization.In Italy the first tests were carried out in 2014 for research purpose and now approximately 10 centers are collecting data and are experiencing a consistency in repeating exams.Currently in Italian centers children at pre-school age are the main target: in this population it is important to have a sensitive and feasible test, non-invasive, that can be performed at tidal volume without sedation, and requiring minimal cooperation and coordination, and that can be used longitudinally over time. Another target could be the transplanted subjects to detect early signs of lung function decline.The content of this paper captures the experience and discussions among some of the Italian centers where LCI is currently used for research and/or in clinical practice about the method and the need to have a common approach.The aim of this paper is not to describe the methodology of MBW, but to inform the pediatric community about the possible application of LCI in CF.
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http://dx.doi.org/10.1186/s13052-019-0647-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6498565PMC
May 2019

Clinical research as foundation for the advancement of respiratory physiotherapy.

Monaldi Arch Chest Dis 2019 Mar 29;89(1). Epub 2019 Mar 29.

ASST Grande Ospedale Metropolitano Niguarda, Department of Cardiothoracic and Vascular Surgery.

Associazione Riabilitatori dell'Insufficienza Respiratoria (ARIR) is pleased to announce a new editorial project by joining the Monaldi Archives of Chest Disease journal.
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http://dx.doi.org/10.4081/monaldi.2019.1059DOI Listing
March 2019

Quantitative multivolume proton-magnetic resonance imaging in patients with cystic fibrosis lung disease: comparison with clinical indicators.

Eur Respir J 2019 05 2;53(5). Epub 2019 May 2.

Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milan, Italy.

This cross-sectional study aims to verify the relationship between quantitative multivolume proton-magnetic resonance imaging (H-MRI) and clinical indicators of ventilatory abnormalities in cystic fibrosis (CF) lung disease.Non-enhanced chest MRI, spirometry and multiple breath washout was performed by 28 patients (10-27 years) with CF lung disease. Images acquired at end-inspiration and end-expiration were registered by optical flow to estimate expiratory-inspiratory proton-density change (ΔH-MRI) as a measure of regional ventilation. Magnetic resonance images were also evaluated using a CF-specific scoring system.Biomarkers of CF ventilation impairment were defined from the ΔH-MRI as follows: ΔH-MRI median, ΔH-MRI quartile coefficient of variation (QCV) and percentage of low-ventilation volume (%LVV). Imaging biomarkers correlated to all the clinical measures of ventilation abnormality, with the strongest correlation between ΔH-MRI median and forced expiratory volume in 1 s (r=0.44, p<0.001), ΔH-MRI QCV and lung clearance index (LCI) (r=0.51, p<0.001) and %LVV and LCI (r=0.66, p<0.001). Correlations were also found between imaging biomarkers of ventilation and morphological scoring.The study showed a significant correlation between quantitative multivolume MRI and clinical indicators of CF lung disease. MRI, as a non-ionising imaging technique, may be particularly attractive in CF care for longitudinal evaluation, providing a new imaging biomarker to detect early ventilatory abnormalities.
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http://dx.doi.org/10.1183/13993003.02020-2017DOI Listing
May 2019

Ventilation inhomogeneity is associated with OGTT-derived insulin secretory defects in cystic fibrosis.

Pediatr Pulmonol 2019 02 21;54(2):141-149. Epub 2018 Dec 21.

Department of Food, Environmental and Nutritional Sciences, International Centre for the Assessment of Nutritional Status, University of Milan, Milan, Italy.

Progressive deterioration of β-cell function is the main mechanism underlying diabetes in cystic fibrosis (CF). Diabetes negatively impacts the clinical status of CF patients years before its onset. We aimed to evaluate if OGTT-derived indices of β-cell function are associated with early markers of lung disease. We carried out a cross-sectional study on 80 CF patients who performed OGTT, spirometry, and nitrogen-multiple breath washout test. β-cell glucose sensitivity and the insulinogenic indices were used as markers of β-cell function and first-phase insulin response to glucose stimulus. We used sex- and age-adjusted multiple linear regression models to estimate the association between OGTT-derived indices and lung function measures. An increment of β-cell glucose sensitivity equal to its interquartile range was associated with an increase in ppFEV of 7.6 points (95%CI: 0.8; 14.4) as well as with a decrease in LCI of -1.96 units (95%CI: -3.40; -0.51) and in S of -0.016 L (95%CI: -0.026; -0.007). The corresponding figures for insulinogenic index were: 8.6 (95%CI: 3.4; 13.9) for ppFEV , -2.03 (95%CI: -3.13; -0.94) for LCI, and -0.014 L (95%CI: -0.021; -0.071) for S . When adjusting also for 2-h plasma glucose, both β-cell glucose sensitivity and insulinogenic index remained inversely associated with S . Deterioration of β-cell function is related to early lung disease in young patients with mild to normal pulmonary function. This relationship is independent from hyperglycemia and mainly involves conductive airways.
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http://dx.doi.org/10.1002/ppul.24212DOI Listing
February 2019

Evidence-Based Medicine: Can We Trust the Evidence Informing Clinical Practice?

Authors:
Simone Gambazza

J Allied Health 2018 ;47(4):296-299

Cystic Fibrosis Centre, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via della Commenda 9, 20121 Milan, Italy. Tel +390255032460.

An attempt to distinguish science from folklore in medical practice was made in 1991, when a new paradigm called evidence-based medicine (EBM) officially appeared. Although this approach was meant to avoid clinical entropy, it might constitute a barrier for contemporary health enhancement, generating results that could be selectively chosen or obtained through misapplication of frequent statistics. At worst, only few health professions can take advantage from this supposed demarcation criterion, lacking the infrastructure and institutional support to carry on research and thus offering a risky disservice to patients. The potential of technology applied to health should be investigated further, and exploring and learning from other approaches than EBM should be encouraged, taking into account the way in which we assess reality and the biological substrate of our learning processes.
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March 2019

Respiratory physiotherapy education in Italy: .

Authors:
Simone Gambazza

Breathe (Sheff) 2018 Sep;14(3):250-252

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Cystic Fibrosis Centre, Milan, Italy.

At the start of my career, following 3 years of undergraduate education in physiotherapy, it was crystal clear that I was more inclined to the respiratory field rather than musculoskeletal or neurological practice. At that time, after six enthusiastic months spent at Lacor Hospital (Gulu, Uganda) writing my graduation thesis, my remaining options were a 2-year Master's level degree (MSc), introduced in Italy in late 2004, randomly following some educational courses offered by the only Italian association of physiotherapists dealing with respiratory disease (Associazione Riabilitatori dell'Insufficienza Respiratoria; ARIR) or, eventually, deepening my understanding and, therefore, management of respiratory diseases through the available 1-year postgraduate track at the University of Milan (Milan, Italy). The MSc was about some nonspecific aspects of physiotherapy, such as health management, economics and general research issues, while the postgraduate course, established in 2006 and currently celebrating its 13th edition, was offering 60 university training credits (Crediti Formativi Universitari; CFU), equivalent to approximately 1500 hours of work (lessons, individual study, preparation for the exam, research work, .). Taking into consideration the fact that a bachelor's degree in physiotherapy is obtained after 180 CFU and that the average amount of hours dedicated to the respiratory area corresponds, more or less, to less than 10% of the total CFU, it was not difficult for me to opt for the 1-year postgraduate track.
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http://dx.doi.org/10.1183/20734735.021918DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6118882PMC
September 2018

Expiratory muscle strength and functional exercise tolerance in adults with cystic fibrosis: a cross-sectional study.

Physiother Res Int 2018 Oct 26;23(4):e1720. Epub 2018 Jun 26.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Cystic Fibrosis Centre, Milano, Italy.

Objective: A 6-minute walk work (6MWW), that is the product of distance walked at the 6-minute walk test (6MWT) multiplied by body weight, has been suggested as an appropriate variable for estimating functional capacity. Under the hypothesis that 6MWW strongly correlates with expiratory muscle strength (P max), as found in Chronic Obstructive Pulmonary Disease (COPD), the aim of the study was to determine the degree of this correlation in adults with cystic fibrosis.

Methods: A cross-sectional study was carried out at the Regional Referral Centre for Cystic Fibrosis, where patients with cystic fibrosis attending their regular follow-up, aged 18 years or older with mild-to-normal lung disease, were asked to participate. Dietitians determined nutritional status before subjects performed spirometry and static measurement of respiratory muscles. The 6MWT was performed as the last study procedure. Spearman correlation test was used to correlate P max with 6MWW and other study variables.

Results: Twenty-five cystic fibrosis subjects aged 18-30 years and with FEV values ranging from 42.4% to 123.4% predicted completed the study. P max strongly correlated with 6MWW (rho .72, p = .0001) whereas it did not correlate with other study variables, including distance at the 6MWT. Distance walked multiplied by body weight (p = .0019) and body mass index (p = .0238) were significantly lower in those with P max below the lower limits of normal.

Conclusion: Increased functional exercise tolerance is related to higher static expiratory pressure in patients with mild-to-normal cystic fibrosis lung disease. Difference in exercise performance might reflect a possible difference in body composition that needs to be further investigated.
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http://dx.doi.org/10.1002/pri.1720DOI Listing
October 2018

Ventilatory limitation and dynamic hyperinflation during exercise testing in Cystic Fibrosis.

Pediatr Pulmonol 2017 01 13;52(1):29-33. Epub 2016 Oct 13.

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Cystic Fibrosis Centre, University of Milan, Milan, Italy.

Objective: To investigate the presence of dynamic hyperinflation after the Modified Shuttle Test (MST) and its relationship with lung function, exercise tolerance, and clinical symptoms in Cystic Fibrosis (CF).

Methods: Retrospective observational study. Subjects in clinically stable condition with a CF diagnosis based on a positive sweat test (chloride >60 mEq/L) and/or presence of two disease causing mutations, with available data on MST, spirometry, maximal voluntary ventilation, and inspiratory capacity manoeuvres were considered for the analysis. Breathing reserve was calculated and a threshold value of 0.7 was subsequently chosen as a value of pulmonary mechanical limit. Subjects were then categorized into two groups according to the change in the inspiratory capacity from rest to peak exercise. Unconditional logistic regression was used to estimate unadjusted odds ratios, 95% confidence intervals and P-values.

Results: Twenty-two subjects demonstrated evidence of dynamic hyperinflation during the MST. Thirteen out of 22 subjects were ventilatory limited during exercise including 5 of those without evidence of dynamic hyperinflation (P = 0.24). No combination of variables resulted in a parsimonious regression model.

Conclusions: Dynamic hyperinflation is common in CF and it is not associated with traditionally defined ventilatory limitation parameters during the MST. Pediatr Pulmonol. 2017;52:29-33. © 2016 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ppul.23572DOI Listing
January 2017

Pilot Randomized Controlled Trial Evaluating the Effect of Hypertonic Saline With and Without Hyaluronic Acid in Reducing Inflammation in Cystic Fibrosis.

J Aerosol Med Pulm Drug Deliv 2016 12 5;29(6):482-489. Epub 2016 May 5.

1 Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Cystic Fibrosis Centre , Milan, Italy .

Background: Hypertonic saline (HS) has been established as a therapy aimed at restoring the surface liquid of airways liquid and enhancing mucociliary clearance in patients with cystic fibrosis (CF). A formula containing 7% HS and 0.1% hyaluronic acid (HA) is also available, basing its use on the protective effects of HA against elastin injury and on its greater ease of administration (i.e., the perceived acceptability of inhalation). This study explores the effect of HA+HS in reducing the inflammation of airways, by measuring cytokine levels in sputum, its safety profile, and the prevalence of commonly reported symptoms like cough, throat irritation, and saltiness.

Methods: In a pilot, double-blind, randomized controlled, parallel-group, 1:1 trial, clinically stable CF patients older than 6 years of age and with a FEVpred. >40% were randomized to one of the treatment arms, HS or HS+HA, to be administered twice a day at home. Clinical data, inflammatory markers (IL-1β, IL-6, IL-8, IL-10, TNF-α, VEGF) in sputum, and judgments on the tolerability and pleasantness were collected at the beginning and after 28 days.

Results: HA+HS had no significant effect on inflammatory markers versus HS alone, as shown by broad confidence intervals. In the HS+HA group, the highest decrement from baseline values was observed for IL-1β (-58.8%) followed by VEGF (-49.9%), whereas in the HS group a significant increment of IL-10 levels (+83.0%; p = 0.011) was the only significant finding. Prevalence of unfavorable scores was 36.8% in HA+HS versus 55% in HS group (p = 0.207); no significant differences were detected in the prevalence of moderate/severe symptoms of cough, saltiness, and throat irritation in pulmonary functions tests after 28 days.

Conclusions: HS+HA administration in CF patients does not show any significant effects on lung inflammation and function as compared to HS alone.
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http://dx.doi.org/10.1089/jamp.2015.1256DOI Listing
December 2016

Aerosol delivery practice in Italian Cystic Fibrosis centres: a national survey.

Arch Physiother 2016 15;6. Epub 2016 Jan 15.

Cystic Fibrosis Centre, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, Italy.

Background: Physiotherapists (PTs) are ideally positioned to assist patients and families with inhalation therapies through monitoring, communication and education about available therapies and their proper use; indeed aerosoltherapy management is listed as part of Italian PTs' core competence and in the core syllabus for post-graduate training in respiratory physiotherapy. The aim of this study was to outline the involvement of Italian PTs working in Cystic Fibrosis (CF) centres in the aerosol delivery practice.

Methods: Physiotherapist coordinators ( = 29) of all Italian CF centres were invited to participate in a cross-sectional survey and a semi-structured questionnaire was developed and sent by e-mail.

Results: A response rate of 69 % was achieved. The majority of participants were woman and the overall mean professional experience was twenty years. Italian PTs are involved in the aerosol delivery practice, managing education, drug-device combination, dilution and mixing of drugs.

Conclusions: Physiotherapists play a key role in the care of Italian CF patients; nevertheless the Italian Group of Physiotherapists might plan interventions to harmonize the aerosol delivery practice in Italian CF centres and to sustain continuing education.
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http://dx.doi.org/10.1186/s40945-016-0015-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5759924PMC
January 2016

Pulse oximetry oxygen saturation during the 6-min walk test: a limit for stopping the test without resuming it.

Eur Respir J 2015 Oct;46(4):1222-3

IRCCS Salvatore Maugeri Foundation, Scientific Institute of Pavia, Division of Pulmonary rehabilitation, Pavia, Italy.

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http://dx.doi.org/10.1183/13993003.00670-2015DOI Listing
October 2015

Active Video Game Playing in Children and Adolescents With Cystic Fibrosis: Exercise or Just Fun?

Respir Care 2015 Aug 21;60(8):1172-9. Epub 2015 Apr 21.

Cystic Fibrosis Centre, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.

Background: Xbox Kinect has been proposed as an exercise intervention in cystic fibrosis (CF), but its potential has not been compared with standard training modalities.

Methods: Using a crossover design, subjects were randomized to 2 intervention groups: Xbox Kinect and a traditional stationary cycle. Heart rate, SpO2, dyspnea, and fatigue were measured. Subject satisfaction was tested.

Results: Thirty subjects with CF (11 males, mean ± SD age of 12 ± 2.5 y, mean ± SD FEV1 of 73 ± 16% of predicted) were enrolled. Xbox Kinect provided a cardiovascular demand similar to a stationary cycle, although the modality was different (interval vs. continuous). Maximum heart rates were similar (P = .2). Heart rate target was achieved more frequently with a stationary cycle (P = .02). Xbox Kinect caused less dyspnea (P = .001) and fatigue (P < .001) and was more enjoyable than a stationary cycle (P < .001).

Conclusions: Subjects preferred Xbox Kinect for its interactivity. Xbox Kinect has the potential to be employed as an exercise intervention in young subjects with CF, but investigation over longer periods is needed.
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http://dx.doi.org/10.4187/respcare.03576DOI Listing
August 2015

Isocapnic hyperpnea with a portable device in Cystic Fibrosis: an agreement study between two different set-up modalities.

J Clin Monit Comput 2015 Oct 28;29(5):569-72. Epub 2014 Oct 28.

Cystic Fibrosis Centre, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via della Commenda 9, 20122, Milan, Italy.

To evaluate the bias and precision of the respiratory muscle training device formulas to predict respiratory minute volume (RMV) and volume of the reservoir bag (BV) on a cohort of subjects with Cystic Fibrosis (CF). CF patients with available pulmonary function tests and maximal voluntary manoeuvres were included in the study. Vital capacity and maximal voluntary ventilation were extracted from subjects' records and then inserted to the manufacturer's formulas to obtain RMV and BV (measured setting). RMV and BV were compared according to standard and measured formulas in males and females. Sample was described and then processed using Bland-Altman analysis. Bland-Altman analysis for RMV revealed a bias and precision of 8.8 ± 29 L/min in males and 28.8 ± 16 L/min in females; 0.4 ± 0.5 L in males and 0.7 ± 0.4 L in females for BV. Concordance correlation coefficients for RMV were -0.03 in males and 0.02 in females; 0.22 in males and 0.03 in females for BV, reinforcing an unsatisfactory concordance between measured and manufacturer setting. This study shows considerable discrepancies between the two methods, making the degree of agreement not clinically acceptable. This might cause inappropriate setting and disservice to patients with CF.
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http://dx.doi.org/10.1007/s10877-014-9633-zDOI Listing
October 2015

Human rhinovirus infection in children with cystic fibrosis.

Jpn J Infect Dis 2014 ;67(5):399-401

Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico.

Nasopharyngeal swabs obtained from 78 pediatric patients with cystic fibrosis (CF), including 47 with acute pulmonary exacerbation and 31 in a stable clinical condition, were evaluated for 17 respiratory viruses. Human rhinovirus (HRV) was the most frequently detected virus in patients with pulmonary exacerbation and in those who were clinically stable (21.3% vs. 12.9%; P = 0.52). HRV-A was the main RV detected in patients with pulmonary exacerbations. However, no prevalence of particular HRV-A subtypes was found. This study highlights that RV is frequently found in the respiratory secretions of patients with CF and the impact of HRV-A appears higher than that of the other HRV types in patients with pulmonary exacerbations.
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July 2015

CPAP in cystic fibrosis: is it time to surrender yet?

Respir Care 2013 Sep;58(9):e116-7

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http://dx.doi.org/10.4187/respcare.02655DOI Listing
September 2013
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