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

Acute Respiratory Distress Syndrome Clinical Trial

— OSCILLATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474656
• Other study ID #: 164451
• Status: Completed
• Phase: N/A
• First received: May 15, 2007
• Last updated: January 29, 2009
• Start date: June 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Canadian Critical Care Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• High-frequency oscillation

• Conventional lung-open mechanical ventilation

Locations

Country	Name	City	State
Canada	University of Alberta Medical Centre	Edmonton	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Mt Sinai Hospital	Toronto	Ontario
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	St Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Saudi Arabia	King Fahad National Guard Hospital	Riyadh

Sponsors (4)

Lead Sponsor	Collaborator
Canadian Critical Care Trials Group	Canadian Institutes of Health Research (CIHR), McMaster University, University of Toronto

Countries where clinical trial is conducted

Canada,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence to our explicit mechanical ventilation protocols;		duration of mechanical ventilation
Primary	to measure and understand the reasons for crossovers between groups		duration of mechanical ventilation
Primary	to estimate the rate of patient recruitment, and understand barriers to recruitment
Primary	to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment