The oscillation for Acute Respiratory Distress Syndrome (ARDS) treated early (OSCILLATE) pilot study
| ISRCTN | ISRCTN42992782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42992782 |
| ClinicalTrials.gov number | NCT00474656 |
| Secondary identifying numbers | MCT-82966 |
- Submission date
- 31/05/2007
- Registration date
- 31/05/2007
- Last edited
- 06/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maureen Meade
Scientific
Scientific
McMaster University
Hamilton Health Sciences Centre, Rm. 2C9
1200 Main Street
Hamilton
Ontario
L8N 3Z5
Canada
| Phone | +1 (0)905 525 9140 ext. 22900 |
|---|---|
| meadema@hhsc.ca |
Dr Niall D Ferguson
Scientific
Scientific
Toronto Western Hospital
399 Bathurst Street
F2-150
Toronto
M5T 2S8
Canada
| Phone | +1 (0)416 603 6203 |
|---|---|
| n.ferguson@utoronto.ca |
Study information
| Study design | Randomised parallel two-armed multicentre trial in therapeutic management strategy, with data analysts blinded |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | High frequency oscillation versus lung-protective ventilation using conventional ventilators to reduce Acute Respiratory Distress Syndrome (ARDS) mortality: a randomised, parallel, two armed, multicentre pilot trial |
| Study acronym | OSCILLATE Pilot |
| Study objectives | This is a pilot study to test the feasibility of a larger trial for which we hypothesise that high frequency oscillation will reduce acute respiratory distress syndrome (ARDS) mortality compared to lung-protective ventilation using conventional ventilators. |
| Ethics approval(s) | Research Ethics Board of University Health Network, Toronto, Ontario (Canada), 03/05/2007, ref: 07-0158-B |
| Health condition(s) or problem(s) studied | Acute respiratory distress syndrome (ARDS) |
| Intervention | 1. High frequency oscillation (HFO): duration of mechanical ventilation 2. Lung open ventilation: duration of mechanical ventilation |
| Intervention type | Other |
| Primary outcome measure | 1. Feasibility at one-year of study. The three feasibility outcomes for the OSCILLATE pilot study will be evaluated as follows: 1.1. We will consider adherence to our explicit mechanical ventilation protocols to be adequate if more than 80% of patients (approximately 24/30) have fewer than 10% of monitored values (excluding crossover periods) as major protocol violations 1.2. We will consider the number of crossovers to be acceptable if fewer than 10% of patients cross over to the alternate ventilator, when not allowed by protocol 1.3. We will consider patient accrual to be adequate if we recruit 60 patients from 10 sites over one-year |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/05/2007 |
| Completion date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Patients of either sex, 16 years and above 2. Acute onset of respiratory failure, with fewer than two weeks of new pulmonary symptoms 3. Endotracheal intubation or tracheostomy 4. Hypoxaemia: defined as a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) ratio of less than or equal to 200 mmHg 5. Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph |
| Key exclusion criteria | 1. Remaining duration of mechanical ventilation less than 48 hours, as judged by the attending physician 2. Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin 3. Lack of commitment to ongoing life support 4. Weight less than 35 kg 5. Severe chronic respiratory disease 6. Morbid obesity: defined as greater than 1 kg/cm body height 7. Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided) 8. Neuromuscular disease that will result in prolonged need for mechanical ventilation 9. Previous enrolment in this trial 10. All inclusion criteria present for greater than 72 hours 11. On high frequency oscillator (HFO) at the time of screening |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 31/07/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
McMaster University
Ontario
L8N 3Z5
Canada
L8N 3Z5
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
c/o Mrs Peggy Austin
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
| Phone | +1 (0)905 525 9140 |
|---|---|
| austinp@mcmaster.ca | |
| Website | http://www.mcmaster.ca/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (ref: MCT-82966)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/02/2013 | Yes | No | |
| Results article | eligible nonenrolled patients results | 01/12/2015 | Yes | No |
Editorial Notes
06/04/2016: Publication reference added.
