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
  Purpose

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
Acute Lung Injury
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Study Start Date: June 2007
Study Completion Date: November 2007
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521625

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

No publications provided

ClinicalTrials.gov Identifier: NCT00521625     History of Changes
Other Study ID Numbers: PALIVE1
Study First Received: August 24, 2007
Last Updated: May 21, 2008
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 18, 2014