Incidence of Acute Lung Injury in Children

Completed

• Conditions: Acute Lung Injury; Children
• Interventions: Other: Evaluation oxygenation under standard ventilator settings

• Registration Number: NCT01142544
• Lead Sponsor: Dr. Negrin University Hospital

Brief Summary

Acute lung injury in children is a syndrome of rapid onset of acute respiratory failure and require admission into intensive care units (ICU) for advanced life support. There are almost no information on epidemiology of acute lung injury. Published studies do not have information for an entire year and none of them have evaluated the degree of oxygenation failure under standard ventilator settings. The investigators will perform a 1-year prospective audit of all patients admitted with acute lung injury in a network of pediatric ICUs in Spain.

Detailed Description

We will evaluate oxygenation under standard ventilator settings (FiO2 0.5 and 1 on PEEP 5 or 10 cmH2O) in pediatric acute respiratory distress syndrome.

Outcome measures will include: overall ICU mortality, number of patients meeting ARDS criteria at 24 hours, and stratification of patients depending on PaO2/FiO2 ratio at 24 h of meeting acute respiratory distress syndrome criteria.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-23
• Last Update Posted: 2013-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Acute onset of respiratory failure
• Age 1 month to 18 years old
• Bilateral pulmonary infiltrates on Chest X-ray
• Absence of left ventricular failure, PaO2/FiO2>300 mmHg

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric ALIEN	Evaluation oxygenation under standard ventilator settings	All children from 1 month to 18 years old meeting the American-European Consensus Conference definition of acute lung injury

Primary Outcome Measures

Name	Time	Method
Number of cases of acute lung injury per 100,000 population	1 year

Secondary Outcome Measures

Name	Time	Method
Assessment of degree of lung severity at onset and at 24 h of the onset of acute lung injury	1-year

Trial Locations

Locations (1)

Jesús Villar; 🇪🇸 Las Palmas de Gran Canaria, Las Palmas, Spain