The oscillation for acute respiratory distress syndrome (ARDS) treated early trial
| ISRCTN | ISRCTN87124254 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87124254 |
| ClinicalTrials.gov number | NCT01506401 |
| Secondary identifying numbers | MCT-94829 |
- Submission date
- 30/04/2009
- Registration date
- 11/05/2009
- 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 Niall Ferguson
Scientific
Scientific
Toronto Western Hospital
399 Bathurst St., 2MCL-411M
Toronto
M5T 2S8
Canada
| Phone | +1 (0)416 603 6203 |
|---|---|
| n.ferguson@utoronto.ca |
Dr Maureen Meade
Scientific
Scientific
McMaster University
Faculty of Health Sciences
Department of Clinical Epidemiology & Biostatistics, HSC-2C12
1200 Main St W
Hamilton
L8N 3Z5
Canada
| Phone | +1 (0)905 525 9140 ext. 22160 |
|---|---|
| meadema@hhsc.ca |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| 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 best current conventional ventilation to reduce acute respiratory distress syndrome (ARDS) mortality: a multicentre randomised controlled trial |
| Study acronym | OSCILLATE |
| Study objectives | What is the effect of early high frequency oscillation (HFO) versus best current conventional ventilation (CV) using HFO only as rescue therapy, on all-cause hospital mortality among patients with severe early acute respiratory distress syndrome (ARDS)? |
| Ethics approval(s) | 1. University Health Network (University of Toronto) - approval pending as of 11/05/2009 2. Hamilton Health Sciences (McMaster University) - approval pending as of 11/05/2009 All other centres will seek ethics approval before recruiting participants. |
| Health condition(s) or problem(s) studied | Acute respiratory distress syndrome (ARDS) |
| Intervention | Intervention group: high frequency oscillatory (HFO) ventilation using a lung-open approach and an explicit protocol. Control group: conventional ventilation using low tidal volumes, a lung-open approach and an explicit protocol, and utilising HFO only as true rescue therapy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | All-cause in-hospital mortality |
| Secondary outcome measures | 1. Mortality at other time-points (ICU discharge, 28-day) 2. Barotrauma 3. Organ dysfunction 4. Duration of mechanical ventilation 5. Duration of ICU and hospital stay 6. Quality of life at 6 months |
| Overall study start date | 01/06/2009 |
| Completion date | 01/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1200 (actual number recruited by end of recruitment: 548) |
| Key inclusion criteria | 1. Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms 2. Endotracheal intubation or tracheostomy 3. Hypoxaemia - defined as a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) less than or equal to 200 mmHg on FiO2 greater than or equal to 0.5, regardless of positive end expiratory pressure (PEEP) 4. Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph 5. Aged 16 years or over, either sex. No upper age limit. In addition, to qualify for randomisation, patients are assessed on the following ventilator settings: 6. Mode: pressure control or volume control or pressure support 7. FiO2 greater than 0.6 (or higher if necessary to keep pulse oximetric saturation [SpO2] greater than 90%) 8. PEEP greater than 10 cm H2O (or greater if necessary to keep SpO2 greater than 90%) 9. 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 randomisation; if PaO2/FiO2 greater than 200 mmHg, standardised hypoxaemia assessments are repeated at least once daily for the following 72 hours (providing the eligibility criteria are still met). |
| 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 circulatory overload due to, for example, congestive heart failure, hyper-resuscitation, or need for dialysis 3. Suspected pulmonary haemorrhage syndrome 4. 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) 5. Aged less than 16 years 6. Weight less than 35 kg 7. Severe chronic respiratory disease, as indicated by any of: 7.1. Baseline forced expriatory volume in one second (FEV1) less than 20 ml/kg predicted body weight 7.2. Pre-existing chronic interstitial lung disease with chronic interstitial infiltration on chest X-ray 7.3. 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) 7.4. 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 artery pressure [PAP] greater than 40 mmHg), or ventilator dependency 8. Morbid obesity - defined as greater than 1 kg/cm body height 9. Underlying pre-existing condition with expected 6-month mortality greater than 50% 10. Neurological conditions with risk of intracranial hypertension (where hypercapnia should be avoided) 11. Neuromuscular disease that will result in prolonged need for mechanical ventilation, including (but not limited to): 11.1. Guillain Barré syndrome 11.2. Cervical spinal cord injury 12. Previous randomisation in this trial 13. All inclusion criteria present for greater than 72 hours in study intensive care unit (ICU) 14. On HFO at the time of screening |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 29/08/2012 |
Locations
Countries of recruitment
- Canada
- Chile
- France
- Germany
- India
- Saudi Arabia
- Singapore
- Spain
- United Kingdom
- United States of America
Study participating centre
Toronto Western Hospital
Toronto
M5T 2S8
Canada
M5T 2S8
Canada
Sponsor information
Canadian Critical Care Trials Group (Canada)
Research organisation
Research organisation
c/o Dr. John Marshall
St. Michael's Hospital
Toronto
M5M 27K
Canada
| caone@smh.toronto.on.ca | |
| Website | http://www.ccctg.ca |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research
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.
