The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
- Conditions
- Acute Respiratory Distress Syndrome
- Registration Number
- NCT00474656
- Lead Sponsor
- Canadian Critical Care Trials Group
- Brief Summary
Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- Patients of either sex, 16 years and above;
- Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms;
- Endotracheal intubation or tracheostomy;
- Hypoxaemia - defined as a PaO2/FiO2 ≤ 200 mm Hg;
- Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph
- Remaining duration of mechanical ventilation < 48 hours, as judged by the attending physician;
- Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin;
- Lack of commitment to ongoing life support;
- Weight < 35 kg;
- Severe chronic respiratory disease
- Morbid obesity - defined as > 1 kg / cm body height;
- Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided);
- Neuromuscular disease that will result in prolonged need for mechanical ventilation;
- Previous enrolment in this trial;
- All inclusion criteria present for > 72 hours;
- On HFO at the time of screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method adherence to our explicit mechanical ventilation protocols; duration of mechanical ventilation to measure and understand the reasons for crossovers between groups duration of mechanical ventilation to estimate the rate of patient recruitment, and understand barriers to recruitment to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
St Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
King Fahad National Guard Hospital
🇸🇦Riyadh, Saudi Arabia
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
University of Alberta Medical Centre
🇨🇦Edmonton, Alberta, Canada
Mt Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
St. Joseph's Hospital
🇨🇦Hamilton, Ontario, Canada