The Oscillation for Acute Respiratory Distress Syndrome (ARDS) Treated Early (OSCILLATE) Trial

NCT ID: NCT01506401

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 548 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-09-30

Brief Summary

What is the effect of early high frequency oscillation (HFO) versus a lung-protective conventional ventilation (CV) strategy (using HFO only as rescue therapy), on all-cause hospital mortality among patients with severe early acute respiratory distress syndrome (ARDS)?

Detailed Description

High frequency oscillation is theoretically ideal for lung protection. Based on a strong physiological rationale, rapidly expanding use internationally, and promising results in early small RCTS, a definitive RCT to establish the impact of HFO versus current conventional ventilation on mortality is needed. We have completed a pilot multicentre RCT in preparation for this trial, with goals of investigating patient recruitment, protocol acceptance, and crossover rates. The pilot study met all objectives including recruitment that exceeded expectations (94 patients), and very good adherence to protocol. Results of the multinational OSCILLATE Trial will establish the impact of HFO versus conventional ventilation on mortality rates among adults with severe ARDS.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Study Design

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

Study Groups

Conventional Ventilation

Low tidal volumes, relatively high PEEP.

Group Type: ACTIVE_COMPARATOR

Lung Protective Ventilation

Intervention Type: PROCEDURE

Tidal Volume 6ml/kg; plateau pressure \< or = 35cmH20; Prescribed PEEP/FiO2 chart

High Frequency Oscillation

Open-lung strategy for high frequency oscillation.

Group Type: EXPERIMENTAL

SensorMedics 3100B High Frequency Oscillatory Ventilator

Intervention Type: DEVICE

High Frequency Oscillation

Interventions

SensorMedics 3100B High Frequency Oscillatory Ventilator

High Frequency Oscillation

Intervention Type: DEVICE

Lung Protective Ventilation

Tidal Volume 6ml/kg; plateau pressure \< or = 35cmH20; Prescribed PEEP/FiO2 chart

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms;
• Endotracheal intubation or tracheostomy;
• Hypoxaemia - defined as a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) less than or equal to 200mmHg on FiO2 greater than or equal to 0.5, regardless of positive end expiratory pressure (PEEP)
• Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph

In addition, to qualify for randomization, patients are assessed on the following ventilator settings:

• Mode: pressure control or volume control or pressure support
• FiO2 greater than 0.6 (or higher if necessary to keep pulse oximetric saturation [SpO2] greater than 90%)
• PEEP greater than 10 cm H2O (or greater if necessary to keep SpO2 greater than 90%)
• Tidal volume 6 ml/kg predicted body weight (PBW)

After at least 30 minutes on these settings, we sample arterial blood to assess oxygenation. If PaO2 is less than or equal to 200 mmHg, the patient qualifies for randomization; if PaO2/FiO2 greater than 200 mmHg, standardized hypoxaemia assessments are repeated at least once daily for the following 72 hours (providing eligibility criteria are still met).

• On HFO at the time of screening

Exclusion Criteria

• Remaining duration of mechanical ventilation less than 48 hours, as judged by the attending physician
• Primary cause of acute respiratory failure judged by attending physician to be circulatory overload due to, for example, congestive heart failure, hyper-resuscitation, or need for dialysis
• Suspected pulmonary haemorrhage syndrome
• Lack of commitment to ongoing life support (note that this does not include the presence of a "Do Not Resuscitate" order alone, if there is a commitment to ongoing life support
• Aged less than 16 years or greater than 85 years
• Weight less than 35 kg
• Severe chronic respiratory disease, as indicated by any of:
• Baseline forced expiratory volume in one second (FEV1) less than 20 ml/kg predicted body weight
• Pre-existing chronic interstitial lung disease with chronic interstitial infiltration on chest x-ray
• Documented chronic carbon dioxide (CO2) retention (partial pressure of carbon dioxide in arterial blood [PaCO2] less than 50 mmHg) and/or chronic hypoxaemia(PaO2 less than 55 mmHg on FiO2=0.21)
• Chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vascular disease resulting in severe exercise restriction (e.g., unable to climb stairs or perform household duties), secondary polycythaemia, severe pulmonary hypertension (mean pulmonary arterial pressure [PAP] greater than 40 mmHg), or ventilator dependency
• Morbid obesity - defined as greater than 1 kg/cm body height
• Underlying pre-existing condition with expected 6-month mortality greater than 50%
• Neurological conditions with risk of intracranial hypertension (where hypercapnia should be avoided)
• Neuromuscular disease that will result in prolonged need for mechanical ventilation, including (but not limited to):
• Guillain Barre syndrome
• Cervical spinal cord injury
• Previous randomization in this trial

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 85 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

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niall D Ferguson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Maureen O Meade, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Denver Health Medical Centre

Denver, Colorado, United States

Orlando Regional Medical Centre

Orlando, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Hospital of the University ofPennsylvania

Philadelphia, Pennsylvania, United States

Parkland Memorial Hospital

Dallas, Texas, United States

University of Texas HSC

Houston, Texas, United States

Texas A&M HSC College of Medicine, Scott & White Hospital

Temple, Texas, United States

Peter Lougheed Centre/Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta Medical Centre

Edmonton, Alberta, Canada

St Paul's Hospital

Vancouver, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Vancouver Island Health Research Centre

Victoria, British Columbia, Canada

Health Sciences Centre, Winnipeg

Winnipeg, Manitoba, Canada

Royal Victoria Hospital

Barrie, Ontario, Canada

St. Joseph's Healthcare, McMaster University

Hamilton, Ontario, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

University of Western Ontario - University Hospital

London, Ontario, Canada

University of Western Ontario - Victoria Hospital

London, Ontario, Canada

Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada

Ottawa Hospital-General Campus

Ottawa, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

St Josephs

Toronto, Ontario, Canada

St Michael's Hospital

Toronto, Ontario, Canada

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

William Osler Health Centre

Toronto, Ontario, Canada

Maisonneuve Rosemont

Montreal, Quebec, Canada

Centre Hosptialier de liUniersite de Montreal - CHUM- Saint Luc

Montreal, Quebec, Canada

Patrick Bellemare

Montreal, Quebec, Canada

Hopital de l'Enfant-Jesus

Québec, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

Clinica Las Lilas

Santiago, , Chile

Pontificia Universidad Catolica de Chile

Santiago, , Chile

Deenanath Mangeshkar Hospital & Research Centre

Pune, , India

King Faisal Specialist Hospital & Research Centre

Jeddah, , Saudi Arabia

King Fahad National Guard Hospital

Riyadh, , Saudi Arabia

Riyadh Armed Forces

Riyadh, , Saudi Arabia

Countries

United States; Canada; Chile; India; 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

ISRCTN87124254

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCT94829

Identifier Type: -

Identifier Source: org_study_id