Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury
NCT ID: NCT00521625
Last Updated: 2008-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
OBSERVATIONAL
2007-06-30
2007-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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St. Justine's Hospital
OTHER
Principal Investigators
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Philippe Jouvet, MD
Role: PRINCIPAL_INVESTIGATOR
St. Justine's Hospital
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital at Oakland
Oakland, California, United States
The Children's Hospital
Denver, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Miami Children's Hospital
Miami, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Kentucky Children's Hospital
Lexington, Kentucky, United States
UMAss Memorial Medical Center
Worchester, Massachusetts, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Children's Hospital
Omaha, Nebraska, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Darmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Penn State Children's Hospital
Hershey, Pennsylvania, United States
The Children's hospital Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Austin
Austin, Texas, United States
Texas Childrens Hospital
Houston, Texas, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Akademisches Lehrkrankenhaus
Feldkirch, , Austria
Medical University of Vienna
Vienna, , Austria
Paola Childrens Hospital
Antwerp, , Belgium
Cliniques universitaires Saint-Luc
Brussels, , Belgium
Hôpital SteJustine
Montreal, Quebec, Canada
Montreal Children' Hospital
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, 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
Québec, , Canada
BC Children's Hospital
Vancouver, , Canada
CHU Lille
Lille, , France
CHU Nantes
Nantes, , France
Hôpital Robert-Debré
Paris, , France
Necker
Paris, , France
CHU Pontchaillou
Rennes, , France
University Clinic Frankfurt
Frankfurt, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Kinderzentrum im Klinikum Nürnberg
Nuremberg, , Germany
Children's Hospital StAugustin
Sankt Augustin, , Germany
University Children's Hospital
Tuebringen, , Germany
Ospedali riuniti di Bergamo
Bergamo, , Italy
Padua University Hospital
Padua, , Italy
Azienda Ospedaliera di Verona
Verona, , Italy
The Wilhelmina Children's Hospital
Utrecht, , Netherlands
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 Compostela, , Spain
Hospital Infantil La Fe
Valencia, , Spain
The Queen Silvia Children's Hospital
Gothenburg, , Sweden
Astrid Lindgren Children's Hospital
Stockholm, , Sweden
Children's Hospital
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Bristol Children's Hospital
Bristol, , United Kingdom
Countries
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Related Links
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Web site for the study's data collection
Other Identifiers
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PALIVE1
Identifier Type: -
Identifier Source: org_study_id