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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61546997
Enrollment
980
Registered
2005-08-11
Start date
2000-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill Patients with Acute Lung Injury (ALI) Respiratory Acute lung injury (ALI)

Interventions

Control Ventilation Strategy (assist control
low airway pressures
standard PEEP) Experimental Lung Open Ventilation Strategy (pressure control
low tidal volumes
recruitment maneuvers). For further information, please contact Dr Meade at the address listed below or Dr Thomas Stewart at University of Toronto (tstewart@mtsinai.on.ca).

Sponsors

McMaster University (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: 1. Primary cause of respiratory failure is cardiac 2. Anticipated duration of mechanical ventilation 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

Design outcomes

Primary

MeasureTime frame
Hospital Mortality

Secondary

MeasureTime frame
1. Mortality attributed to respiratory failure 2. Duration of respiratory failure and duration of mechanical failure 3. Evaluation of respiratory function during mechanical ventilation 4. Incidence of barotrauma 5. Non-respiratory organ dysfunction

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026