Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury (PALIVE1)

This study has been completed.
Sponsor:
Information provided by:
St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT00521625
First received: August 24, 2007
Last updated: May 21, 2008
Last verified: May 2008

August 24, 2007
May 21, 2008
June 2007
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Complete list of historical versions of study NCT00521625 on ClinicalTrials.gov Archive Site
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Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury
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)

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.

Observational
Time Perspective: Prospective
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  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2007
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Inclusion Criteria:

  • Child on invasive mechanical ventilation administered through an endotracheal tube or a tracheostomy tube, or on non-invasive mechanical ventilation administered through a nasal or facial mask or a nasal canula or helmet at 9 a.m. on the day of the study.
  • Presence of ALI as estimated by the attending physician:

    1. Onset of hypoxemia was acute
    2. Bilateral infiltrates on chest X-Ray
    3. No clinical evidence of congestive heart failure
    4. Sustained hypoxemia defined as:

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)

Exclusion Criteria:

  • Post conceptional age < 42 weeks
  • Age > 18 years
  • Non-corrected cyanotic congenital heart disease or evidence of extra-pulmonary right to left shunt
  • Withdrawal/withholding of care
  • Brain death
  • No consent, if required
  • Patient on ECMO
  • Already included in this study
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00521625
PALIVE1
No
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St. Justine's Hospital
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Principal Investigator: Philippe Jouvet, MD Hôpital Ste-Justine
St. Justine's Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP