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

This study has been completed.

First Received: May 15, 2007 Last Updated: January 29, 2009 History of Changes

Sponsors and Collaborators:	Canadian Critical Care Trials Group Canadian Institutes of Health Research (CIHR) McMaster University University of Toronto
Information provided by:	Canadian Critical Care Trials Group
ClinicalTrials.gov Identifier:	NCT00474656

Purpose

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	Intervention
Acute Respiratory Distress Syndrome	Device: High-frequency oscillation Device: Conventional lung-open mechanical ventilation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study

Further study details as provided by Canadian Critical Care Trials Group:

Primary Outcome Measures:

adherence to our explicit mechanical ventilation protocols; [ Time Frame: duration of mechanical ventilation ]
to measure and understand the reasons for crossovers between groups [ Time Frame: 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

Enrollment:	94
Study Start Date:	June 2007
Study Completion Date:	December 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474656

Locations

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

Sponsors and Collaborators

Canadian Critical Care Trials Group

Canadian Institutes of Health Research (CIHR)

McMaster University

University of Toronto

Investigators

Principal Investigator:	Niall D Ferguson, MD, MSc	University of Toronto
Principal Investigator:	Maureen O Meade, MD, MSc	McMaster University

More Information

No publications provided

Study ID Numbers:	164451
Study First Received:	May 15, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00474656 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Canadian Critical Care Trials Group:

high frequency oscillation
lung-protective ventilation
ARDS
ventilator-induced lung injury

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute Respiratory Distress Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Respiratory Tract Diseases
Lung Diseases

Syndrome
Respiration Disorders
Respiratory Distress Syndrome, Adult

ClinicalTrials.gov processed this record on May 07, 2009