A randomised trial of a Lung-Open Ventilation Strategy in acute lung injury

Completed

• Conditions: Critically Ill Patients with Acute Lung Injury (ALI); Respiratory; Acute lung injury (ALI)

• Registration Number: ISRCTN61546997
• Lead Sponsor: McMaster University (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 980

Inclusion Criteria

Persons of either sex 18 years and older.
1. Invasive mechanical ventilation
2. Acute respiratory insufficiency (within past 28 days)
3. Bilateral infiltrates on frontal chest radiograph
4. Hypoxemia, defined as paO2/FiO2 less than or equal to 250, on any amount of Positive End-Expiratory Pressure (PEEP)

Exclusion Criteria

1. Primary cause of respiratory failure is cardiac
2. Anticipated duration of mechanical ventilation <48 hours, as judged by the intensivist
3. Inability to wean from other experimental ventilation strategies
4. Severe chronic respiratory disease
5. Neuromuscular disease that will result in prolonged need for mechanical ventilation
6. Conditions where hypercapnia-induced intracranial hypertension should be avoided
7. Morbid obesity (>1 kg per cm body weight)
8. Pregnancy
9. Very unlikely to survive in the judgment of the investigator, and luck of commitment to life support
10. Malignancy or underlying irreversible condition with 6 month mortality greater than or equal to 50%
11. Greater than 48 hours elapsed since first eligible in study hospital
12. Current participation in competing trial
13. Lack of physician, patient or proxy consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified