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

NCT01506401 | Terminated Phase 3 DMC

• 2 other identifiers: MCT94829ISRCTN87124254
• Study Type: interventional
• Target: 548
• Locations: 5 countries
• Sites: 38

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)?

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• All-cause hospital mortality

  all-cause hospital mortality

  Randomised patients will be ventilated according to their assigned ventilation strategy for up to 60 days, until they die on the ventilator or are successfully (for >24 hours) liberated from mechanical ventilation.

Secondary Outcomes (6)

• Mortality at other time-points

  Duration of hospitalization (ICU discharge, 60 days)

• Barotrauma

  ICU discharge or 60 days

• Organ Dysfunction

  Duration of hospitalization or 60 days

• Duration of mechanical ventilation

  Duration of hospitalization or 60 days

• Duration of ICU & Hospital Stay

  Duration of hospitalization which may exceed 60 days

Study Arms (2)

Conventional Ventilation

ACTIVE COMPARATOR

Low tidal volumes, relatively high PEEP.

Procedure: Lung Protective Ventilation

High Frequency Oscillation

EXPERIMENTAL

Open-lung strategy for high frequency oscillation.

Device: SensorMedics 3100B High Frequency Oscillatory Ventilator

Interventions

SensorMedics 3100B High Frequency Oscillatory Ventilator DEVICE

High Frequency Oscillation

High Frequency Oscillation

Lung Protective Ventilation PROCEDURE

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

Conventional Ventilation

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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):

Sponsors & Collaborators

• Canadian Critical Care Trials Group: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• McMaster University: collaborator
• University of Toronto: collaborator

Study Sites (38)

Denver Health Medical Centre

Denver, Colorado, 80204, United States

Location

Orlando Regional Medical Centre

Orlando, Florida, 32806, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5033, United States

Location

Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27858, United States

Location

Hospital of the University ofPennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Parkland Memorial Hospital

Dallas, Texas, 75390-8558, United States

Location

University of Texas HSC

Houston, Texas, 77030, United States

Location

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

Temple, Texas, 76508, United States

Location

Peter Lougheed Centre/Foothills Medical Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

University of Alberta Medical Centre

Edmonton, Alberta, Canada

Location

St Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Vancouver Island Health Research Centre

Victoria, British Columbia, V8R 1J8, Canada

Location

Health Sciences Centre, Winnipeg

Winnipeg, Manitoba, Canada

Location

Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

St. Joseph's Healthcare, McMaster University

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

University of Western Ontario - University Hospital

London, Ontario, N6A 5A5, Canada

Location

University of Western Ontario - Victoria Hospital

London, Ontario, N6C 6B5, Canada

Location

Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Ottawa Hospital-General Campus

Ottawa, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

St Josephs

Toronto, Ontario, M6R 1B5, Canada

Location

St Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

William Osler Health Centre

Toronto, Ontario, Canada

Location

Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hosptialier de liUniersite de Montreal - CHUM- Saint Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Patrick Bellemare

Montreal, Quebec, H4J 1C5, Canada

Location

Hopital de l'Enfant-Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

Centre hospitalier universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Clinica Las Lilas

Santiago, Chile

Location

Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

Deenanath Mangeshkar Hospital & Research Centre

Pune, India

Location

King Faisal Specialist Hospital & Research Centre

Jeddah, Saudi Arabia

Location

King Fahad National Guard Hospital

Riyadh, Saudi Arabia

Location

Riyadh Armed Forces

Riyadh, Saudi Arabia

Location

Related Publications (2)

• 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.

  PMID: 26192398 DERIVED

• 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.

  PMID: 23339639 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Niall D Ferguson, MD, MSc

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Maureen O Meade, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: January 10, 2012
• Study Start: June 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 6, 2015

Record last verified: 2012-09

Locations

SA (3); CL (2); IN (1); US (8); CA (24)