Acute Respiratory Distress SyndromeOSCILLATENCT00474656
The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
A study testing High-frequency oscillation and Conventional lung-open mechanical ventilation in people with Acute Respiratory Distress Syndrome, run by Canadian Critical Care Trials Group at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- High-frequency oscillation and Conventional lung-open mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jun 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada11 sites
University of Alberta Medical Centre
Edmonton, Alberta
Hamilton Health Sciences
Hamilton, Ontario
St. Joseph's Hospital
Hamilton, Ontario
Royal Columbian Hospital
New Westminster, British Columbia
Ottawa Hospital
Ottawa, Ontario
Mt Sinai Hospital
Toronto, Ontario
St Michael's Hospital
Toronto, Ontario
Sunnybrook Health Science Centre
Toronto, Ontario
University Health Network
Toronto, Ontario
St Paul's Hospital
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
About this study
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
- Being tested
- High-frequency oscillation, Conventional lung-open mechanical ventilation
- Keywords
- high frequency oscillation, lung-protective ventilation, ARDS, ventilator-induced lung injury
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency oscillationDevice
Conventional lung-open mechanical ventilationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to our explicit mechanical ventilation protocols;
Measured: duration of mechanical ventilation
to measure and understand the reasons for crossovers between groups
Measured: duration of mechanical ventilation
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Critical Care Trials Group
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McMaster University, University of Toronto
- Investigators
- Niall D Ferguson, MD, MSc, Principal investigator, University of TorontoMaureen O Meade, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474656
- Sponsor's protocol ID
- 164451
- Acronym
- OSCILLATE
- Status last verified
- Jan 2009
- First submitted
- 15 May 2007
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26192398Ferguson 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.
PubMed 23339639
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
- ClinicalTrials.gov ID
- NCT00474656
- Acronym / sponsor ID
- OSCILLATE / 164451
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- high frequency oscillation, lung-protective ventilation, ARDS, ventilator-induced lung injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Canadian Critical Care Trials GroupUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McMaster University, University of Toronto
- Study start
- Jun 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-frequency oscillation | Device | – |
| Conventional lung-open mechanical ventilation | Device | – |
Primary outcome
adherence to our explicit mechanical ventilation protocols;
Time frame: duration of mechanical ventilation
to measure and understand the reasons for crossovers between groups
Time frame: duration of mechanical ventilation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
- Derived from this study: PubMed 26192398Arabi 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.
- Derived from this study: PubMed 23339639Ferguson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niall D Ferguson, MD, MSc principal investigator
University of Toronto
Maureen O Meade, MD, MSc principal investigator
McMaster University
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency oscillation and Conventional lung-open mechanical ventilation in people with Acute Respiratory Distress Syndrome, run by Canadian Critical Care Trials Group at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to our explicit mechanical ventilation protocols; (time frame: duration of mechanical ventilation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00474656, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2009.