Status:
COMPLETED
Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.
Detailed Description
To compare an innovative Lung Open Ventilation strategy with a proven low tidal volume strategy, hypothesizing that the Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, an...
Eligibility Criteria
Inclusion
- Invasive mechanical ventilation
- Acute respiratory insufficiency (within past 28 days)
- Bilateral infiltrates on frontal chest radiograph
- Hypoxemia, defined as PaO2/FiO2\<=250
Exclusion
- Primary cause of respiratory failure is cardiac
- Anticipated duration of mechanical ventilation \< 48 hours
- Inability to wean other experimental ventilation strategies
- Severe chronic respiratory disease
- Neuromuscular disease that will prolong mechanical ventilation
- Conditions where hypercapnia-induced intracranial hypertension should be avoided
- Morbid obesity (\> 1Kg per cm body weight)
- Pregnancy
- Very unlikely to survive and lack of commitment to life support Underlying irreversible condition with 6 month mortality \>= 50%
- Greater than 48 hours elapsed since first eligible
- Current participation in competing trial
- Lack of physician, patient or proxy consent
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
980 Patients enrolled
Trial Details
Trial ID
NCT00182195
Start Date
August 1 2000
End Date
March 1 2006
Last Update
April 23 2007
Active Locations (1)
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1
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, Canada, L8L 5G4