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

This study has been terminated.
(Enrolment halted by Steering Committee on advice from Data Monitoring Committee.)
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McMaster University
University of Toronto
Information provided by (Responsible Party):
Canadian Critical Care Trials Group
ClinicalTrials.gov Identifier:
NCT01506401
First received: December 14, 2011
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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)?


Condition Intervention Phase
Acute Respiratory Distress Syndrome (ARDS)
Device: SensorMedics 3100B High Frequency Oscillatory Ventilator
Procedure: Lung Protective Ventilation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Oscillation for ARDS Treated Early (OSCILLATE) Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • All-cause hospital mortality [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    all-cause hospital mortality


Secondary Outcome Measures:
  • Mortality at other time-points [ Time Frame: Duration of hospitalization (ICU discharge, 60 days) ] [ Designated as safety issue: Yes ]
    mortality at other time-points (ICU discharge, 60 days)

  • Barotrauma [ Time Frame: ICU discharge or 60 days ] [ Designated as safety issue: Yes ]
    Barotrauma

  • Organ Dysfunction [ Time Frame: Duration of hospitalization or 60 days ] [ Designated as safety issue: Yes ]
    Organ Dysfunction

  • Duration of mechanical ventilation [ Time Frame: Duration of hospitalization or 60 days ] [ Designated as safety issue: Yes ]
    Duration of mechanical ventilation

  • Duration of ICU & Hospital Stay [ Time Frame: Duration of hospitalization which may exceed 60 days ] [ Designated as safety issue: Yes ]
    Duration of ICU & Hospital Stay

  • Quality of Life at 6 months [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
    Quality of Life at 6 months post randomization


Enrollment: 548
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Ventilation
Low tidal volumes, relatively high PEEP.
Procedure: Lung Protective Ventilation
Tidal Volume 6ml/kg; plateau pressure < or = 35cmH20; Prescribed PEEP/FiO2 chart
Experimental: High Frequency Oscillation
Open-lung strategy for high frequency oscillation.
Device: SensorMedics 3100B High Frequency Oscillatory Ventilator
High Frequency Oscillation

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.

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  • All inclusion criteria present for greater than 73 hours in study intensive care unit (ICU)
  • On HFO at the time of screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506401

  Hide Study Locations
Locations
United States, Colorado
Denver Health Medical Centre
Denver, Colorado, United States, 80204
United States, Florida
Orlando Regional Medical Centre
Orlando, Florida, United States, 32806
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-5033
United States, North Carolina
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27858
United States, Pennsylvania
Hospital of the University ofPennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75390-8558
University of Texas HSC
Houston, Texas, United States, 77030
Texas A&M HSC College of Medicine, Scott & White Hospital
Temple, Texas, United States, 76508
Canada, Alberta
Peter Lougheed Centre/Foothills Medical Centre
Calgary, Alberta, Canada, T1Y 6J4
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
Vancouver Island Health Research Centre
Victoria, British Columbia, Canada, V8R 1J8
Canada, Manitoba
Health Sciences Centre, Winnipeg
Winnipeg, Manitoba, Canada
Canada, Ontario
Royal Victoria Hospital
Barrie, Ontario, Canada, L4M 6M2
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Joseph's Healthcare, McMaster University
Hamilton, Ontario, Canada, L8N 4A6
University of Western Ontario - Victoria Hospital
London, Ontario, Canada, N6C 6B5
University of Western Ontario - University Hospital
London, Ontario, Canada, N6A 5A5
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
University Health Network
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
St Michael's Hospital
Toronto, Ontario, Canada
St Josephs
Toronto, Ontario, Canada, M6R 1B5
William Osler Health Centre
Toronto, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Canada, Quebec
Centre Hosptialier de liUniersite de Montreal - CHUM- Saint Luc
Montreal, Quebec, Canada, H2X 3J4
Patrick Bellemare
Montreal, Quebec, Canada, H4J 1C5
Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Hopital de l'Enfant-Jesus
Quebec, Canada, G1J 1Z4
Chile
Clinica Las Lilas
Santiago, Chile
Pontificia Universidad Catolica de Chile
Santiago, Chile
India
Deenanath Mangeshkar Hospital & Research Centre
Pune, India
Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Jeddah, Saudi Arabia
King Fahad National Guard Hospital
Riyadh, Saudi Arabia
Riyadh Armed Forces
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

Additional Information:
No publications provided by Canadian Critical Care Trials Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Canadian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT01506401     History of Changes
Other Study ID Numbers: MCT94829, ISRCTN87124254
Study First Received: December 14, 2011
Last Updated: September 5, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Canadian Critical Care Trials Group:
ARDS
ventilator-induced lung injury
lung protective ventilation
high frequency oscillation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on July 20, 2014