Publications by authors named "Peter M Luckett"

14 Publications

  • Page 1 of 1

Postdischarge Outcome Domains in Pediatric Critical Care and the Instruments Used to Evaluate Them: A Scoping Review.

Crit Care Med 2020 12;48(12):e1313-e1321

Pediatric Critical Care Medicine, Department of Pediatrics, University of Washington School of Medicine, Seattle, WA.

Objectives: Assessing outcomes after pediatric critical illness is imperative to evaluate practice and improve recovery of patients and their families. We conducted a scoping review of the literature to identify domains and instruments previously used to evaluate these outcomes.

Design: Scoping review.

Setting: We queried PubMed, EMBASE, PsycINFO, Cumulative Index of Nursing and Allied Health Literature, and the Cochrane Central Register of Controlled Trials Registry for studies evaluating pediatric critical care survivors or their families published between 1970 and 2017. We identified articles using key words related to pediatric critical illness and outcome domains. We excluded articles if the majority of patients were greater than 18 years old or less than 1 month old, mortality was the sole outcome, or only instrument psychometrics or procedural outcomes were reported. We used dual review for article selection and data extraction and categorized outcomes by domain (overall health, emotional, physical, cognitive, health-related quality of life, social, family).

Subjects: Manuscripts evaluating outcomes after pediatric critical illness.

Interventions: None.

Measurements And Main Results: Of 60,349 citations, 407 articles met inclusion criteria; 87% were published after 2000. Study designs included observational (85%), interventional (7%), qualitative (5%), and mixed methods (3%). Populations most frequently evaluated were traumatic brain injury (n = 96), general pediatric critical illness (n = 87), and congenital heart disease (n = 72). Family members were evaluated in 74 studies (18%). Studies used a median of 2 instruments (interquartile range 1-4 instruments) and evaluated a median of 2 domains (interquartile range 2-3 domains). Social (n = 223), cognitive (n = 183), and overall health (n = 161) domains were most frequently studied. Across studies, 366 unique instruments were used, most frequently the Wechsler and Glasgow Outcome Scales. Individual domains were evaluated using a median of 77 instruments (interquartile range 39-87 instruments).

Conclusions: A comprehensive, generalizable understanding of outcomes after pediatric critical illness is limited by heterogeneity in methodology, populations, domains, and instruments. Developing assessment standards may improve understanding of postdischarge outcomes and support development of interventions after pediatric critical illness.
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http://dx.doi.org/10.1097/CCM.0000000000004595DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708523PMC
December 2020

Clinical Efficacy of Vibrating Mesh and Jet Nebulizers With Different Interfaces in Pediatric Subjects With Asthma.

Respir Care 2020 Oct 24;65(10):1451-1463. Epub 2020 Mar 24.

Department of Respiratory Care, Texas State University, Round Rock, Texas.

Background: Nebulizers are commonly used in emergency departments to deliver bronchodilators to children with asthma exacerbations. However, no clinical study comparing a vibrating mesh nebulizer with a jet nebulizer is available in this patient population. The purpose of this study was to compare the clinical efficacy of a vibrating mesh nebulizer to a jet nebulizer combined with a mouthpiece or mask in children with asthma exacerbations admitted to the emergency department.

Methods: We conducted a single-blinded randomized clinical trial of 217 children (2-18 y old) with a moderate to severe asthma exacerbation in the emergency department. Assessment of severity was defined by our acute asthma score, adapted from the Pediatric Asthma Score. Subjects were randomized to receive bronchodilator treatment via vibrating mesh nebulizer ( = 108) or jet nebulizer ( 109) and were treated until they achieved a mild asthma score and were discharged or until a decision to admit was made. All subjects were treated per our acute asthma clinical pathway algorithm for the emergency department with modifications to allow for blinding, assessment of treatment, and data collection. Outcome variables included hospital admission rate, number of treatments, and time to mild asthma score.

Results: There was a significant difference in baseline asthma score between subjects treated with the vibrating mesh nebulizer and those treated with the jet nebulizer ( = .042), but no other significant differences in demographics existed between groups. To adjust for effect of baseline asthma score, a multiple logistic regression model was used to model admission. The vibrating mesh nebulizer group had a lower probability of being admitted to the hospital ( = .062), and they required significantly fewer treatments ( < .001) and less time to reach a mild asthma score ( = .004) than those in the jet nebulizer group. In subjects with a mask interface, the vibrating mesh nebulizer significantly reduced the probability of admission ( = .032).

Conclusions: Subjects treated with a vibrating mesh nebulizer required significantly fewer treatments and less time to achieve a mild asthma score. In subjects with a mask interface, the vibrating mesh nebulizer significantly reduced the probability of admission compared to jet nebulizer. (ClinicalTrials.gov registration NCT02774941.).
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http://dx.doi.org/10.4187/respcare.07538DOI Listing
October 2020

Long-Term Neurobehavioral and Quality of Life Outcomes of Critically Ill Children after Glycemic Control.

J Pediatr 2020 03 3;218:57-63.e5. Epub 2020 Jan 3.

Division of Medical Critical Care, Department of Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, MA.

Objectives: To investigate adaptive skills, behavior, and quality health-related quality of life in children from 32 centers enrolling in the Heart And Lung Failure-Pediatric INsulin Titration randomized controlled trial.

Study Design: This prospective longitudinal cohort study compared the effect of 2 tight glycemic control ranges (lower target, 80-100 mg/dL vs higher target, 150-180 mg/dL) 1-year neurobehavioral and health-related quality of life outcomes. Subjects had confirmed hyperglycemia and cardiac and/or respiratory failure. Patients aged 2-16 years old enrolled between April 2012 and September 2016 were studied at 1 year after intensive care discharge. The primary outcome, adaptive skills, was assessed using the Vineland Adaptive Behavior Scale. Behavior and health-related quality of life outcomes were assessed as secondary outcomes using the Pediatric Quality of Life and Child Behavior Checklist at baseline and 1-year follow-up. Group differences were evaluated using regression models adjusting for age category, baseline overall performance, and risk of mortality.

Results: Of 369 eligible children, 358 survived after hospital discharge and 214 (60%) completed follow-up. One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± 25.5 vs 79.4 ± 26.9, lower vs higher target; P = .20). Improvement in Pediatric Quality of Life total health from baseline was greater in the higher target group (adjusted mean difference, 8.2; 95% CI, 1.1-15.3; P = .02).

Conclusions: One-year adaptive behavior in critically ill children with lower vs higher target glycemic control did not differ. The higher target group demonstrated improvement from baseline in overall health. This study affirms the lack of benefit of lower glucose targeting.

Trial Registration: ClinicalTrials.gov: NCT01565941.
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http://dx.doi.org/10.1016/j.jpeds.2019.10.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122648PMC
March 2020

A Survey of Pediatric Critical Care Providers on the Presence, Severity, and Assessment of Capillary Leak in Critically Ill Children.

J Pediatr Intensive Care 2017 Sep 26;6(3):145-151. Epub 2016 Sep 26.

Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut, United States.

 To determine provider opinions on factors most commonly used to assess the presence and severity of pathologic capillary leak in critically ill children.  We conducted an electronic survey of pediatric critical care providers. Patient scenarios were presented to assess opinions on the risk, presence, and clinical significance of capillary leak. Responses were obtained using Likert scales and multiple-choice questions.  A total of 160 responses were analyzed. Respondents agreed that capillary leak is present in the scenario with septic shock while respondents somewhat agreed that it is also present with poly-trauma, cardiac arrest, or cardiopulmonary bypass. They agreed that physical exam, but neither agreed nor disagreed that laboratory tests, can be used to assess and follow the severity of capillary leak in these children. Generalized edema, increase in weight, and pulmonary crackles were commonly identified parameters for assessing capillary leak. The patient factor most commonly identified with capillary leak was presence of infection, while treatment factors most commonly identified were cardiopulmonary bypass and general anesthesia.  There is agreement that capillary leak is common in critically ill children and exacerbates disease. The parameters identified in this study may facilitate a more standardized clinical evaluation of pathologic capillary leak for future studies.
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http://dx.doi.org/10.1055/s-0036-1593388DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6260295PMC
September 2017

Tight Glycemic Control in Critically Ill Children.

N Engl J Med 2017 02 24;376(8):729-741. Epub 2017 Jan 24.

From the Division of Medicine Critical Care (M.S.D.A., J.L.A., G.M.S.) and the Department of Cardiology (D.W., L.A.A.), Boston Children's Hospital and Harvard Medical School, Boston; the Division of Pediatric Critical Care, University of Utah Medical School, Primary Children's Hospital, Salt Lake City, and Intermountain Medical Center, Murray - both in Utah (E.L.H.); Children's Hospital of Philadelphia (V.S., V.M.N.) and the Perelman School of Medicine (V.S., M.A.Q.C., V.M.N.) and the School of Nursing (M.A.Q.C.), University of Pennsylvania - all in Philadelphia; Yale School of Medicine, New Haven, CT (E.V.F.); and Children's Medical Center Dallas and the University of Texas Southwestern Medical School, Dallas (P.M.L.).

Background: In multicenter studies, tight glycemic control targeting a normal blood glucose level has not been shown to improve outcomes in critically ill adults or children after cardiac surgery. Studies involving critically ill children who have not undergone cardiac surgery are lacking.

Methods: In a 35-center trial, we randomly assigned critically ill children with confirmed hyperglycemia (excluding patients who had undergone cardiac surgery) to one of two ranges of glycemic control: 80 to 110 mg per deciliter (4.4 to 6.1 mmol per liter; lower-target group) or 150 to 180 mg per deciliter (8.3 to 10.0 mmol per liter; higher-target group). Clinicians were guided by continuous glucose monitoring and explicit methods for insulin adjustment. The primary outcome was the number of intensive care unit (ICU)-free days to day 28.

Results: The trial was stopped early, on the recommendation of the data and safety monitoring board, owing to a low likelihood of benefit and evidence of the possibility of harm. Of 713 patients, 360 were randomly assigned to the lower-target group and 353 to the higher-target group. In the intention-to-treat analysis, the median number of ICU-free days did not differ significantly between the lower-target group and the higher-target group (19.4 days [interquartile range {IQR}, 0 to 24.2] and 19.4 days [IQR, 6.7 to 23.9], respectively; P=0.58). In per-protocol analyses, the median time-weighted average glucose level was significantly lower in the lower-target group (109 mg per deciliter [IQR, 102 to 118]; 6.1 mmol per liter [IQR, 5.7 to 6.6]) than in the higher-target group (123 mg per deciliter [IQR, 108 to 142]; 6.8 mmol per liter [IQR, 6.0 to 7.9]; P<0.001). Patients in the lower-target group also had higher rates of health care-associated infections than those in the higher-target group (12 of 349 patients [3.4%] vs. 4 of 349 [1.1%], P=0.04), as well as higher rates of severe hypoglycemia, defined as a blood glucose level below 40 mg per deciliter (2.2 mmol per liter) (18 patients [5.2%] vs. 7 [2.0%], P=0.03). No significant differences were observed in mortality, severity of organ dysfunction, or the number of ventilator-free days.

Conclusions: Critically ill children with hyperglycemia did not benefit from tight glycemic control targeted to a blood glucose level of 80 to 110 mg per deciliter, as compared with a level of 150 to 180 mg per deciliter. (Funded by the National Heart, Lung, and Blood Institute and others; HALF-PINT ClinicalTrials.gov number, NCT01565941 .).
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http://dx.doi.org/10.1056/NEJMoa1612348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5444653PMC
February 2017

Design and rationale of Heart and Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT): A randomized clinical trial of tight glycemic control in hyperglycemic critically ill children.

Contemp Clin Trials 2017 02 30;53:178-187. Epub 2016 Dec 30.

The Children's Hospital of Philadelphia, University of Pennsylvania, 3401 Civic Center Blvd., Philadelphia, PA 19104, United States. Electronic address:

Objectives: Test whether hyperglycemic critically ill children with cardiovascular and/or respiratory failure experience more ICU-free days when assigned to tight glycemic control with a normoglycemic versus hyperglycemic blood glucose target range.

Design: Multi-center randomized clinical trial.

Setting: Pediatric ICUs at 35 academic hospitals.

Patients: Children aged 2weeks to 17years receiving inotropic support and/or acute mechanical ventilation, excluding cardiac surgical patients.

Interventions: Patients receive intravenous insulin titrated to either 80-110mg/dL (4.4-6.1mmol/L) or 150-180mg/dL (8.3-10.0mmol/L). The intervention begins upon confirmed hyperglycemia and ends when the patient meets study-defined ICU discharge criteria or after 28days. Continuous glucose monitoring, a minimum glucose infusion, and an explicit insulin infusion algorithm are deployed to achieve the BG targets while minimizing hypoglycemia risk.

Measurements And Main Results: The primary outcome is ICU-free days (equivalent to 28-day hospital mortality-adjusted ICU length of stay). Secondary outcomes include 90-day hospital mortality, organ dysfunction scores, ventilator-free days, nosocomial infection rate, neurodevelopmental outcomes, and nursing workload. To detect an increase of 1.25 ICU-free days (corresponding to a 20% relative reduction in 28-day hospital mortality and a one-day reduction in ICU length of stay), 1414 patients are needed for 80% power using a two-sided 0.05 level test.

Conclusions: This trial tests whether hyperglycemic critically ill children randomized to 80-110mg/dL benefit more than those randomized to 150-180mg/dL. This study implements validated bedside support tools including continuous glucose monitoring and a computerized algorithm to enhance patient safety and ensure reproducible bedside decision-making in achieving glycemic control.
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http://dx.doi.org/10.1016/j.cct.2016.12.023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5285511PMC
February 2017

A perspective on early mobilization for adult patients with respiratory failure: Lessons for the pediatric population.

J Pediatr Rehabil Med 2010 ;3(3):215-27

Department of Pediatrics, Pediatric Critical Care, University of Utah, Primary Children's Medical Center, Salt Lake City, UT, USA.

Objective: To summarize the evidence for early mobilization programs in critically ill pediatric and adult patients with respiratory failure. This paper describes our review of the literature and outlines the morbidities associated with immobility, mechanical ventilation and sedation.The clinical management of acutely ill pediatric patients with respiratory failure traditionally consists of mechanical ventilation, sedation and prolonged immobilization. Although the most severely ill patients require these therapies for survival, each therapy comes with adverse consequences. Early mobilization may reduce complications and confer benefit for children with respiratory failure or those who require prolonged mechanical ventilator support.

Design: Systematic review of the literature pertaining to early mobilization in pediatric and adult patients with respiratory failure. We searched Medline, PubMed, CINAHL and Cochrane database of controlled trials. Randomized controlled trials (RCTs), observational cohort studies, case control studies and population-based analysis were considered for inclusion. Two reviewers (MM and EH) independently selected pertinent studies.

Results: No studies of early mobilization in pediatric populations were found. Five adult studies were identified for review; two randomized controlled trials and three observational studies. All studies suggested an improvement in morbidity and economic benefit with implementation of early mobilization.

Conclusions: Early mobilization in critically ill adult patients with respiratory failure is associated with a decrease in duration of sedatives, ventilator dependant days, ICU and hospital length of stay. The paucity of studies of early mobilization suggest that implementation of early mobilization is not widely practiced. Studies of early mobilization therapy in the adult patient requiring prolonged mechanical ventilator support are reviewed, and the physiologic rational and observed obstacles to integration of an early mobilization program are discussed. The adult data and scientific evidence are combined to support an opinion about the possible benefits of early mobilization programs. The generalizability of the findings and the feasibility of implementing early mobilization in critically ill children who require prolonged mechanical ventilator support are also considered.
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http://dx.doi.org/10.3233/PRM-2010-0130DOI Listing
October 2012

Multicenter validation of a computer-based clinical decision support tool for glucose control in adult and pediatric intensive care units.

J Diabetes Sci Technol 2008 May;2(3):357-68

Pulmonary and Critical Care Unit, Massachusetts General Hospital, Boston, Massachusetts 02114, USA.

Introduction: Hyperglycemia during critical illness is common, and intravenous insulin therapy (IIT) to normalize blood glucose improves outcomes in selected populations. Methods differ widely in complexity, insulin dosing approaches, efficacy, and rates of hypoglycemia. We developed a simple bedside-computerized decision support protocol (eProtocol-insulin) that yields promising results in the development center. We examined the effectiveness and safety of this tool in six adult and five pediatric intensive care units (ICUs) in other centers.

Methods: We required attending physicians of eligible patients to independently intend to use intravenous insulin to normalize blood glucose. We used eProtocol-insulin for glucose control for a duration determined by the clinical caregivers. Adults had an anticipated length of stay of 3 or more days. In pediatric ICUs, we also required support or intended support with mechanical ventilation for greater than 24 hours or with a vasoactive infusion. We recorded all instances in which eProtocol-insulin instructions were not accepted and all blood glucose values. An independent data safety and monitoring board monitored study results and subject safety. Bedside nurses were selected randomly to complete a paper survey describing their perceptions of quality of care and workload related to eProtocol-insulin use.

Results: Clinicians accepted 93% of eProtocol-insulin instructions (11,773/12,645) in 100 adult and 48 pediatric subjects. Forty-eight percent of glucose values were in the target range. Both of these results met a priori-defined efficacy thresholds. Only 0.18% of glucose values were < or =40 mg/dl. This is lower than values reported in prior IIT studies. Although nurses reported eProtocol-insulin required as much work as managing a mechanical ventilator, most nurses felt eProtocol-insulin had a low impact on their ability to complete non-IIT nursing activities.

Conclusions: A multicenter validation demonstrated that eProtocol-insulin is a valid, exportable tool that can assist clinicians in achieving control of glucose in critically ill adults and children.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769731PMC
http://dx.doi.org/10.1177/193229680800200304DOI Listing
May 2008

Comparison of intravenous terbutaline versus normal saline in pediatric patients on continuous high-dose nebulized albuterol for status asthmaticus.

Pediatr Emerg Care 2007 Jun;23(6):355-61

University of Oklahoma, Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.

Objective: To determine if the addition of intravenous terbutaline provides any clinical benefit to children with acute severe asthma already on continuous high-dose nebulized albuterol.

Methods: We conducted a prospective, randomized, double blind, placebo-controlled trial on pediatric patients with acute severe asthma presenting to a large inner city tertiary children's emergency department. Consecutive patients between 2 and 17 years of age who failed acute asthma management and needed intensive care unit admission underwent informed consent and were enrolled into the study. Patients not requiring intubation were randomized to receive either intravenous terbutaline or intravenous normal saline while on continuous high-dose nebulized albuterol, ipratropium bromide, and systemic corticosteroids. Outcome measures included a clinical asthma severity score, hours on continuous nebulized albuterol, and duration of stay in the pediatric intensive care unit. In addition, electrocardiograms, electrolytes, lactic acid, and troponin I levels were obtained at routine intervals during the first 24 hours after admission. Patients who significantly worsened while enrolled in the study received intravenous aminophylline according to protocol.

Results: Forty-nine patients were enrolled in the study. Patients on terbutaline had a mean improvement in the clinical asthma severity score over the first 24 hours of 6.5 points compared with 4.8 points in the placebo group (P = 0.073). Patients on terbutaline spent 38.19 hours on continuous nebulized albuterol compared with their placebo counterparts who spent 51.93 hours (P = 0.25). The length of stay in the PICU was on average 12.95 hours longer for those patients in the placebo group as compared with the terbutaline group (P = 0.345). One patient was removed from the study for a significant cardiac dysrhythmia. This patient was in the terbutaline group and recovered without complications. Troponin I values at 12 hours and 24 hours were elevated in 3 patients each, all within the terbutaline group.

Conclusions: No outcome measures demonstrated statistical significance. Outcome measures revealed a trend toward improvement in the terbutaline group. Before recommending routine use of intravenous terbutaline for acute severe asthma, further study to determine safety and efficacy is necessary.
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http://dx.doi.org/10.1097/01.pec.0000278397.63246.33DOI Listing
June 2007

Severe systemic hypersensitivity reaction to ibuprofen: a presentation of systemic lupus erythematosus.

J Rheumatol 2006 Jan 15;33(1):171-2. Epub 2005 Nov 15.

Department of Pediatrics, University of Texas Southwestern Medical School, USA.

We describe the first severe systemic hypersensitivity reaction to ibuprofen in a pediatric patient with previously undiagnosed systemic lupus erythematosus (SLE). An 11-year-old Thai male presented with fever, rash, altered mental status, and hypotension after oral administration of ibuprofen leading to the diagnosis of SLE. Re-dosing with ibuprofen resulted in recurrence of presenting symptoms. Severe hypersensitivity with hypotension can be a rare consequence of the use of ibuprofen in children with collagen vascular disease. When encountered in an otherwise healthy child, a high index of suspicion must be maintained for the diagnosis of SLE.
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January 2006

Cumulative fluid intake minus output is not associated with ventilator weaning duration or extubation outcomes in children.

Pediatr Crit Care Med 2005 Nov;6(6):642-7

Department of Anesthesia, Children's Hospital, Boston, MA, USA.

Objective: The effect of fluid balance on respiratory outcomes for critically ill children has not been evaluated. The only indicator of fluid balance routinely recorded across our intensive care units was estimated fluid intake and output. We sought to determine whether cumulative intake minus output (I-O) at the start of weaning predicted weaning duration and whether cumulative I-O at extubation predicted extubation failure.

Design: Prospective observational study.

Setting: Ten pediatric intensive care units.

Patients: Cumulative I-O was recorded daily for 301 mechanically ventilated children (<18 yrs of age) from November 1999 through April 2001.

Interventions: Cumulative I-O was recorded during a study of weaning strategies and extubation failure in which mechanical ventilation of the majority of patients during weaning and extubation was managed according to a protocol that did not include fluid balance indicators. Outcomes were the time to successful removal of ventilatory support and the rate of initial extubation failure.

Measurements And Main Results: Relationships between cumulative I-O and outcomes were assessed by means of proportional hazards and logistic regression. The mean cumulative I-O per kilogram of ideal body weight at the start of weaning was 101 mL (sd, 180). Cumulative I-O at the time weaning was initiated did not predict duration of mechanical ventilator weaning. The mean cumulative I-O per kilogram of ideal body weight at extubation was 136 mL (sd, 237). Cumulative I-O at extubation did not predict extubation outcome. There was an association between cumulative I-O at extubation and the duration of weaning in cases not managed by a protocol.

Conclusion: Although routinely recorded, cumulative fluid I-O does not appear to have clinical utility in cases managed according to a mechanical ventilator protocol in which tidal volume and oxygenation on minimal levels of ventilator support are systematically tested.
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http://dx.doi.org/10.1097/01.pcc.0000185484.14423.0dDOI Listing
November 2005

Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial.

JAMA 2005 Jul;294(2):229-37

Children's Hospital Boston, Medical-Surgical Intensive Care Unit, 300 Longwood Ave, Boston, MA 02115, USA.

Context: In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known.

Objective: To test the hypothesis that at the end of 28 days infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning.

Design, Setting, And Patients: Multicenter, randomized, controlled clinical trial conducted from August 28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs prone positioning. Randomization was concealed and group assignment was not blinded.

Intervention: Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines.

Main Outcome Measure: Ventilator-free days to day 28.

Results: The trial was stopped at the planned interim analysis on the basis of the prespecified futility stopping rule. There were no differences in the number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5] supine vs 15.6 [8.6] prone; mean difference, -0.2 days; 95% CI, -3.6 to 3.2; P = .91). After controlling for age, Pediatric Risk of Mortality III score, direct vs indirect acute lung injury, and mode of mechanical ventilation at enrollment, the adjusted difference in ventilator-free days was 0.3 days (95% CI, -3.0 to 3.5; P = .87). There were no differences in the secondary end points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P>.99), the time to recovery of lung injury (P = .78), organ-failure-free days (P = .88), and cognitive impairment (P = .16) or overall functional health (P = .12) at hospital discharge or on day 28.

Conclusion: Prone positioning does not significantly reduce ventilator-free days or improve other clinical outcomes in pediatric patients with acute lung injury.
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http://dx.doi.org/10.1001/jama.294.2.229DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1237036PMC
July 2005

The feasibility of conducting clinical trials in infants and children with acute respiratory failure.

Am J Respir Crit Care Med 2003 May 25;167(10):1334-40. Epub 2003 Feb 25.

Department of Anesthesia, Children's Hospital, Boston, MA 02115, USA.

Designing robust clinical trials in critically ill, mechanically ventilated children requires an understanding of the epidemiology and course of pediatric respiratory failure. As part of a clinical trial, we screened all mechanically ventilated children in nine large pediatric intensive care units (ICUs) across North America for 6 consecutive months. Of 6,403 total ICU admissions, 1,096 (17.1%) required mechanical ventilator support for a minimum of 24 hours. Of these, 701 (64%) met one or more exclusion criteria for trial enrollment. Common reasons for exclusion were upper airway obstruction (13.5%) and cyanotic congenital heart disease (11.5%). Life support interventions were restricted for 9.7% of patients, and 5.5% were chronically ventilator dependent. In the patients who were eligible for respiratory failure studies, 62.4% had an acute primary diagnosis of pulmonary disease, 14.2% neurologic disease, and 8.9% cardiac disease. Chronic underlying conditions were present in 43.2% of the patients. The most common acute diagnosis was bronchiolitis in infants (43.6%) and pneumonia in children 1 year old and older (24.5%). Mortality was rare (1.6%), and the median duration of ventilation was 7 days. The design of clinical trials in critically ill children is feasible but must account for the diverse population, infrequent mortality, and short duration of mechanical ventilation.
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http://dx.doi.org/10.1164/rccm.200210-1175OCDOI Listing
May 2003

Effect of mechanical ventilator weaning protocols on respiratory outcomes in infants and children: a randomized controlled trial.

JAMA 2002 Nov;288(20):2561-8

Children's Hospital, MICU, FA-108, 300 Longwood Ave, Boston, MA 02115, USA.

Context: Ventilator management protocols shorten the time required to wean adult patients from mechanical ventilation. The efficacy of such weaning protocols among children has not been studied.

Objective: To evaluate whether weaning protocols are superior to standard care (no defined protocol) for infants and children with acute illnesses requiring mechanical ventilator support and whether a volume support weaning protocol using continuous automated adjustment of pressure support by the ventilator (ie, VSV) is superior to manual adjustment of pressure support by clinicians (ie, PSV).

Design And Setting: Randomized controlled trial conducted in the pediatric intensive care units of 10 children's hospitals across North America from November 1999 through April 2001.

Patients: One hundred eighty-two spontaneously breathing children (<18 years old) who had been receiving ventilator support for more than 24 hours and who failed a test for extubation readiness on minimal pressure support.

Interventions: Patients were randomized to a PSV protocol (n = 62), VSV protocol (n = 60), or no protocol (n = 60).

Main Outcome Measures: Duration of weaning time (from randomization to successful extubation); extubation failure (any invasive or noninvasive ventilator support within 48 hours of extubation).

Results: Extubation failure rates were not significantly different for PSV (15%), VSV (24%), and no protocol (17%) (P =.44). Among weaning successes, median duration of weaning was not significantly different for PSV (1.6 days), VSV (1.8 days), and no protocol (2.0 days) (P =.75). Male children more frequently failed extubation (odds ratio, 7.86; 95% confidence interval, 2.36-26.2; P<.001). Increased sedative use in the first 24 hours of weaning predicted extubation failure (P =.04) and, among extubation successes, duration of weaning (P<.001).

Conclusions: In contrast with adult patients, the majority of children are weaned from mechanical ventilator support in 2 days or less. Weaning protocols did not significantly shorten this brief duration of weaning.
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http://dx.doi.org/10.1001/jama.288.20.2561DOI Listing
November 2002