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

NCT ID: NCT00474656

Last Updated: 2009-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-12-31

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

High-frequency oscillation

Intervention Type: DEVICE

Conventional lung-open mechanical ventilation

Intervention Type: DEVICE

Eligibility 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

• On HFO at the time of screening.

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;

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Canadian Critical Care Trials Group

OTHER

Sponsor Role: lead

Principal Investigators

Niall D Ferguson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Maureen O Meade, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

University of Alberta Medical Centre

Edmonton, Alberta, Canada

Royal Columbian Hospital

New Westminster, British Columbia, Canada

St Paul's Hospital

Vancouver, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

St. Joseph's Hospital

Hamilton, Ontario, 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

King Fahad National Guard Hospital

Riyadh, , Saudi Arabia

Countries

Canada; Saudi Arabia

References

Arabi YM, Cook DJ, Zhou Q, Smith O, Hand L, Turgeon AF, Matte A, Mehta S, Graham R, Brierley K, Adhikari NK, Meade MO, Ferguson ND; Canadian Critical Care Trials Group. Characteristics and Outcomes of Eligible Nonenrolled Patients in a Mechanical Ventilation Trial of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1306-13. doi: 10.1164/rccm.201501-0172OC.

Reference Type: DERIVED

PMID: 26192398 (View on PubMed)

Ferguson ND, Cook DJ, Guyatt GH, Mehta S, Hand L, Austin P, Zhou Q, Matte A, Walter SD, Lamontagne F, Granton JT, Arabi YM, Arroliga AC, Stewart TE, Slutsky AS, Meade MO; OSCILLATE Trial Investigators; Canadian Critical Care Trials Group. High-frequency oscillation in early acute respiratory distress syndrome. N Engl J Med. 2013 Feb 28;368(9):795-805. doi: 10.1056/NEJMoa1215554. Epub 2013 Jan 22.

Reference Type: DERIVED

PMID: 23339639 (View on PubMed)

Other Identifiers

164451

Identifier Type: -

Identifier Source: org_study_id