NCT00521625

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

Geographic Reach
12 countries

58 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

First QC Date

August 24, 2007

Last Update Submit

May 21, 2008

Conditions

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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:
  • Onset of hypoxemia was acute
  • Bilateral infiltrates on chest X-Ray
  • No clinical evidence of congestive heart failure
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (58)

Children's Hospital Los Angeles

Los Angeles, California, United States

Location

Children's Hospital at Oakland

Oakland, California, United States

Location

The Children's Hospital

Denver, Colorado, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Location

Miami Children's Hospital

Miami, Florida, United States

Location

Children's Memorial Hospital

Chicago, Illinois, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, United States

Location

Kentucky Children's Hospital

Lexington, Kentucky, United States

Location

UMAss Memorial Medical Center

Worchester, Massachusetts, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, United States

Location

Children's Hospital

Omaha, Nebraska, United States

Location

Nebraska Medical Center

Omaha, Nebraska, United States

Location

Darmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Location

New York Presbyterian Hospital

New York, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, United States

Location

The Children's hospital Philadelphia

Philadelphia, Pennsylvania, United States

Location

Children's Hospital of Austin

Austin, Texas, United States

Location

Texas Childrens Hospital

Houston, Texas, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Location

Akademisches Lehrkrankenhaus

Feldkirch, Austria

Location

Medical University of Vienna

Vienna, Austria

Location

Paola Childrens Hospital

Antwerp, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, Belgium

Location

Hôpital SteJustine

Montreal, Quebec, Canada

Location

Montreal Children' Hospital

Montreal, Quebec, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Stollery Children's Hospital

Edmonton, Canada

Location

McMaster Children's Hospital

Hamilton, Canada

Location

Children's Hospital of Western Ontario

London, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Canada

Location

BC Children's Hospital

Vancouver, Canada

Location

CHU Lille

Lille, France

Location

CHU Nantes

Nantes, France

Location

Hôpital Robert-Debré

Paris, France

Location

Necker

Paris, France

Location

CHU Pontchaillou

Rennes, France

Location

University Clinic Frankfurt

Frankfurt, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Germany

Location

Kinderzentrum im Klinikum Nürnberg

Nuremberg, Germany

Location

Children's Hospital StAugustin

Sankt Augustin, Germany

Location

University Children's Hospital

Tuebringen, Germany

Location

Ospedali riuniti di Bergamo

Bergamo, Italy

Location

Padua University Hospital

Padua, Italy

Location

Azienda Ospedaliera di Verona

Verona, Italy

Location

The Wilhelmina Children's Hospital

Utrecht, Netherlands

Location

Hospital Sant Joan de Déu-Hospital Clinic

Barcelona, Spain

Location

Cruces Hospital

Bilbao, Spain

Location

General University Hospital Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario Central de Asturias

Oveido, Spain

Location

Hospital universitario de Salamanca

Salamanca, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

Hospital Infantil La Fe

Valencia, Spain

Location

The Queen Silvia Children's Hospital

Gothenburg, Sweden

Location

Astrid Lindgren Children's Hospital

Stockholm, Sweden

Location

Children's Hospital

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Bristol Children's Hospital

Bristol, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Philippe Jouvet, MD

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 28, 2007

Study Start

June 1, 2007

Study Completion

November 1, 2007

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations