Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury (PALIVE1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00521625|
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : May 22, 2008
|First Submitted Date||August 24, 2007|
|First Posted Date||August 28, 2007|
|Last Update Posted Date||May 22, 2008|
|Study Start Date||June 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00521625 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury|
|Official Title||Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury - Phase 1 PALIVE 1 (for Pediatric Acute Lung Injury Mechanical VEntilation Strategies)|
|Brief Summary||PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in children with an acute lung injury (ALI). The objective of the study is to describe mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily clinical practice is heterogenous among pediatric intensivists as few pediatric data exists on optimal mechanical ventilation strategies in this group of patients. Furthermore, different strategies may affect patient outcome.|
INTRODUCTION Few pediatric data exists on the ventilation mode and parameters that would provide the greatest benefit with the least risk to an individual pediatric patient with Acute Lung Injury (ALI). Current expert opinion is that it is reasonable to follow adult recommendations and to adapt clinical management in children according to adult data. In the absence of consensus and established guidelines for mechanical ventilation in children with ALI, we believe that the daily clinical practice in pediatric intensive care units is subject to great variations according to the experience, comfort and knowledge of the attending intensivist.
METHODS Objective: Describe invasive and non-invasive mechanical ventilation in pediatric cases of ALI.
Hypothesis: There is an important variability in the observed practice pattern of mechanical ventilation in pediatric cases of ALI.
Design: An international cross-sectional epidemiologic study in Pediatric Intensive Care Units on the observed practice pattern of invasive and non-invasive mechanical ventilation in children with ALI.
Setting: Pediatric Intensive Care Units in Canada, United States, Europe.
Patients: Patients less than 18 years old on invasive or non-invasive mechanical ventilation with a diagnosis of ALI on the day of the study.
Measurements: Demographic data on included patients; their underlying chronic disease and acute disease leading to non-invasive mechanical ventilation or intubation and mechanical ventilation; data on mechanical ventilation mode and parameters, vital signs, lab results, radiographic findings, treatments, complications of mechanical ventilation will be recorded every 6 hours for 24 hours. A web based case report form will be developed.
Sample size: We plan to conduct the study on isolated days at least one month apart until we reach 200 patients with ALI, to include at least 10 patients on high frequency ventilation. We estimate that with 5 days of study in 70 centers we should reach this number.
FUTURE CONSIDERATIONS We believe this study will provide important data on the actual mechanical ventilation strategies in pediatric patients with ALI. The next step will be to conduct a prospective international study on mechanical ventilation strategies and to follow patients prospectively during the whole course of their mechanical ventilation.
|Study Design||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Not Provided|
|Actual Study Completion Date||November 2007|
|Primary Completion Date||Not Provided|
PaO2(mmHg)/FiO2 ratio ≤ 300 or PaO2(kPa)/FiO2 ≤ 40
If no arterial canula or no arterial blood gas:
SpO2/FiO2 ≤ 320 with SpO2 < 0.98 (10)
|Ages||up to 18 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States|
|Removed Location Countries|
|Other Study ID Numbers||PALIVE1|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||St. Justine's Hospital|
|PRS Account||St. Justine's Hospital|
|Verification Date||May 2008|