The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study

Sponsor

Canadian Critical Care Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00474656

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), McMaster University (Other), University of Toronto (Other)

Enrollment

Locations

Duration (Months)

7.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Device: High-frequency oscillation Device: Conventional lung-open mechanical ventilation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	University of Alberta Medical Centre	Edmonton	Alberta	Canada
2	Royal Columbian Hospital	New Westminster	British Columbia	Canada
3	St Paul's Hospital	Vancouver	British Columbia	Canada
4	Vancouver General Hospital	Vancouver	British Columbia	Canada
5	Hamilton Health Sciences	Hamilton	Ontario	Canada
6	St. Joseph's Hospital	Hamilton	Ontario	Canada
7	Ottawa Hospital	Ottawa	Ontario	Canada
8	Mt Sinai Hospital	Toronto	Ontario	Canada
9	St Michael's Hospital	Toronto	Ontario	Canada
10	Sunnybrook Health Science Centre	Toronto	Ontario	Canada
11	University Health Network	Toronto	Ontario	Canada
12	King Fahad National Guard Hospital	Riyadh		Saudi Arabia