|
Welcome
|
|
25 May 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| The oscillation for Acute Respiratory Distress Syndrome (ARDS) treated early (OSCILLATE) pilot study |
| ISRCTN | ISRCTN42992782 |
| DOI | 10.1186/ISRCTN42992782 |
| ClinicalTrials.gov identifier | NCT00474656 |
| EudraCT number | |
| Public title | The oscillation for Acute Respiratory Distress Syndrome (ARDS) treated early (OSCILLATE) pilot study |
| 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 |
| Acronym | OSCILLATE Pilot |
| Serial number at source | MCT-82966 |
| Study hypothesis | 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. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Research Ethics Board of University Health Network, Toronto, Ontario (Canada) approved on the 3rd May 2007 (ref: 07-0158-B) |
| Study design | Randomised, parallel, two armed, multicentre trial in therapeutic management strategy, with data analysts blinded |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Acute respiratory distress syndrome (ARDS) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/05/2007 |
| Anticipated end date | 31/07/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 60 |
| Interventions |
1. High frequency oscillation (HFO): duration of mechanical ventilation
2. Lung open ventilation: duration of mechanical ventilation Co-investigator for Public and Scientific Queries: Dr Niall D Ferguson Toronto Western Hospital 399 Bathurst Street F2-150 Toronto, Ontario M5T 2S8 Canada Tel: +1 416 603 6203 Fax: +1 416 603 5870 Email: n.ferguson@utoronto.ca |
| Primary outcome measure(s) |
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 measure(s) | No secondary outcome measures |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - www.cihr-irsc.gc.ca (ref: MCT-82966) |
| Trial website | |
| Publications | 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23339639 |
| Contact name | Dr Maureen Meade |
| Address |
McMaster University
Hamilton Health Sciences Centre, Rm. 2C9 1200 Main Street Hamilton |
| City/town | Ontario |
| Zip/Postcode | L8N 3Z5 |
| Country | Canada |
| Tel | +1 905 525 9140 ext. 22900 |
| Fax | +1 905 524 3842 |
| meadema@hhsc.ca | |
| Sponsor | McMaster University (Canada) |
| Address |
c/o Mrs Peggy Austin
1200 Main Street West Hamilton |
| City/town | Ontario |
| Zip/Postcode | L8N 3Z5 |
| Country | Canada |
| Tel | +1 905 525 9140 |
| Fax | +1 905 570 0742 (RESEARCH) |
| austinp@mcmaster.ca | |
| Sponsor website: | http://www.mcmaster.ca/ |
| Date applied | 31/05/2007 |
| Last edited | 20/02/2013 |
| Date ISRCTN assigned | 31/05/2007 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
