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

May 21, 2008 updated by: St. Justine's Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria
        • Akademisches Lehrkrankenhaus
      • Vienna, Austria
        • Medical University of Vienna
  • Belgium
      • Antwerp, Belgium
        • Paola Childrens Hospital
      • Brussels, Belgium
        • Cliniques universitaires Saint-Luc
  • Canada
      • Edmonton, Canada
        • Stollery Children's Hospital
      • Hamilton, Canada
        • McMaster Children's Hospital
      • London, Canada
        • Children's Hospital of Western Ontario
      • Quebec, Canada
        • Centre Hospitalier Universitaire de Quebec
      • Vancouver, Canada
        • BC Children's Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Hôpital SteJustine
      • Montreal, Quebec, Canada
        • Montreal Children' Hospital
      • Sherbrooke, Quebec, Canada
        • Centre Hospitalier Universitaire de Sherbrooke
  • France
      • Lille, France
        • CHU Lille
      • Nantes, France
        • CHU Nantes
      • Paris, France
        • Hôpital Robert-Debré
      • Paris, France
        • NECKER
      • Rennes, France
        • CHU Pontchaillou
  • Germany
      • Frankfurt, Germany
        • University Clinic Frankfurt
      • Mannheim, Germany
        • Universitätsklinikum Mannheim
      • Nurnberg, Germany
        • Kinderzentrum im Klinikum Nürnberg
      • St Augustin, Germany
        • Children's Hospital StAugustin
      • Tuebringen, Germany
        • University Children's Hospital
  • Italy
      • Bergamo, Italy
        • Ospedali Riuniti di Bergamo
      • Padova, Italy
        • PADUA UNIVERSITY HOSPITAL
      • Verona, Italy
        • Azienda Ospedaliera di Verona
  • Netherlands
      • Utrecht, Netherlands
        • The Wilhelmina Children's Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Sant Joan de Déu-Hospital Clinic
      • Bilbao, Spain
        • Cruces Hospital
      • Madrid, Spain
        • General University Hospital Gregorio Maranon
      • Oveido, Spain
        • Hospital Universitario Central de Asturias
      • Salamanca, Spain
        • Hospital Universitario De Salamanca
      • Santiago de Compostella, Spain
        • Hospital Clinico Universitario de Santiago de Compostela
      • Valencia, Spain
        • Hospital Infantil La Fe
  • Sweden
      • Goteborg, Sweden
        • The Queen Silvia Children's Hospital
      • Stockholm, Sweden
        • Astrid Lindgren Children's Hospital
  • Switzerland
      • Geneva, Switzerland
        • Children's Hospital
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Children's Hospital
  • United States
    • California
      • Los Angeles, California, United States
        • Children's Hospital Los Angeles
      • Oakland, California, United States
        • Children's Hospital at Oakland
    • Colorado
      • Denver, Colorado, United States
        • The Children's Hospital
    • Connecticut
      • Hartford, Connecticut, United States
        • Connecticut Children's Medical Center
    • Florida
      • Miami, Florida, United States
        • Miami Children's Hospital
    • Illinois
      • Chicago, Illinois, United States
        • Children's Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States
        • Riley Hospital for Children
    • Kentucky
      • Lexington, Kentucky, United States
        • Kentucky Children's Hospital
    • Massachusetts
      • Worchester, Massachusetts, United States
        • UMass Memorial Medical Center
    • Missouri
      • Kansas City, Missouri, United States
        • Children's Mercy Hospital
    • Nebraska
      • Omaha, Nebraska, United States
        • Nebraska Medical Center
      • Omaha, Nebraska, United States
        • Children's Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Darmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States
        • New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, United States
        • The Children's hospital Philadelphia
    • Texas
      • Austin, Texas, United States
        • Children's Hospital of Austin
      • Houston, Texas, United States
        • Texas Childrens Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Investigators

  • Principal Investigator: Philippe Jouvet, MD, St. Justine's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 28, 2007

Study Record Updates

Last Update Posted (Estimate)

May 22, 2008

Last Update Submitted That Met QC Criteria

May 21, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PALIVE1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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