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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
High-frequency oscillation
Conventional lung-open mechanical ventilation
Sponsored by
Canadian Critical Care Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring high frequency oscillation, lung-protective ventilation, ARDS, ventilator-induced lung injury

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alberta Medical Centre
  • Royal Columbian Hospital
  • St Paul's Hospital
  • Vancouver General Hospital
  • Hamilton Health Sciences
  • St. Joseph's Hospital
  • Ottawa Hospital
  • Mt Sinai Hospital
  • St Michael's Hospital
  • Sunnybrook Health Science Centre
  • University Health Network
  • King Fahad National Guard Hospital

Outcomes

Primary Outcome Measures

adherence to our explicit mechanical ventilation protocols;
to measure and understand the reasons for crossovers between groups
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

Secondary Outcome Measures

Full Information

First Posted
May 15, 2007
Last Updated
January 29, 2009
Sponsor
Canadian Critical Care Trials Group
Collaborators
Canadian Institutes of Health Research (CIHR), McMaster University, University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00474656
Brief Title
The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
Acronym
OSCILLATE
Official Title
The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Canadian Critical Care Trials Group
Collaborators
Canadian Institutes of Health Research (CIHR), McMaster University, University of Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
high frequency oscillation, lung-protective ventilation, ARDS, ventilator-induced lung injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
High-frequency oscillation
Intervention Type
Device
Intervention Name(s)
Conventional lung-open mechanical ventilation
Primary Outcome Measure Information:
Title
adherence to our explicit mechanical ventilation protocols;
Time Frame
duration of mechanical ventilation
Title
to measure and understand the reasons for crossovers between groups
Time Frame
duration of mechanical ventilation
Title
to estimate the rate of patient recruitment, and understand barriers to recruitment
Title
to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niall D Ferguson, MD, MSc
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maureen O Meade, MD, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Medical Centre
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
Country
Canada
Facility Name
St Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Mt Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
King Fahad National Guard Hospital
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
26192398
Citation
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.
Results Reference
derived
PubMed Identifier
23339639
Citation
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.
Results Reference
derived

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

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