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

Completed

Conditions studied: Acute Lung Injury, Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT00521625

Run by

St. Justine's Hospital

Starts

2007-06-01

Expected to finish

2007-11-01

Last updated by the study team

2008-05-22

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Children's Hospital Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.