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

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ClinicalTrials.gov Identifier: NCT00521625
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : May 22, 2008
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Study Description
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.

Condition or disease
Acute Lung Injury Acute Respiratory Distress Syndrome

Detailed Description:

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

Study Type : Observational
Time Perspective: Prospective
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)
Study Start Date : June 2007
Study Completion Date : November 2007

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521625

  Show 58 Study Locations
Sponsors and Collaborators
St. Justine's Hospital
Principal Investigator: Philippe Jouvet, MD St. Justine's Hospital
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00521625     History of Changes
Other Study ID Numbers: PALIVE1
First Posted: August 28, 2007    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Wounds and Injuries
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries