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| [ ...Back to search results ] | [ Print-friendly version ] |
| Conventional positive pressure ventilation or High Frequency Oscillatory Ventilation (HFOV) for adults with acute respiratory distress syndrome |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN10416500 |
| Date ISRCTN assigned | 13/06/2007 |
| Local reference number(s) | HTA 06/04/01; Version 4 - 12 June 2007 (not final) |
| Public title | Conventional positive pressure ventilation or High Frequency Oscillatory Ventilation (HFOV) for adults with acute respiratory distress syndrome |
| Scientific title | |
| Acronym | OSCAR: High Frequency OSCillation in ARDS |
| Disease/condition/study domain | Adults with acute respiratory distress syndrome. Intensive/critical care. |
| Study hypothesis | Patients with Acute Respiratory Distress Syndrome (ARDS) treated with high frequency oscillatory ventilation will have a decreased mortality at 30 days following randomisation compared with patients treated with conventional positive pressure ventilation. |
| Design/methodology | A collaborative randomised controlled trial. |
| Research ethics review | To be submitted as of 13 June 2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Age ≥16 years 2. Weight ≥35 kg 3. Endotracheal intubation or tracheostomy 4. Hypoxaemia defined as an arterial oxygen tension/inspired oxygen ratio (PaO2/FiO2) ratio ≤26.7kPa (200 mmHg), with a Positive End Expiratory Pressure (PEEP) ≥ 5 cmH20, determined on two arterial blood samples 12 hours apart 5. Bilateral infiltrates on chest radiograph 6. One or more risk factors for ARDS (including pneumonia, aspiration of gastric contents, inhalation injury, sepsis, major trauma, multiple transfusions, drug overdose, burn injury, acute pancreatitis, or shock) 7. Predicted to require at least 48 hours of artificial ventilation from the time of randomisation |
| Participants - exclusion criteria | 1. Patients who could not benefit from HFOV 1.1. Patients with left atrial hypertension from any cause, diagnosed clinically or with echocardiography or pulmonary artery catheterisation 1.2. Patients who have been mechanically ventilated for more than 7 days at the point of enrollment 2. Patients in whom HFOV might be hazardous 2.1. Patients with airway disease expected to cause expiratory airflow limitation 2.2. Patients who have had a lung biopsy or resection during this hospital admission 3. Administrative, practical and ethical exclusions 3.1. Patients previously enrolled in the OSCAR trial during the same hospital admission 3.2.Patients refusing consent or patients in whom relatives refuse assent 3.3. Patients who were ¿legally incompetent¿ prior to their hospital admission 3.4. Patients whose relatives do not understand written or verbal information for whom an interpreter is not available 3.5. Patients enrolled in another therapeutic trial in the 30 days prior to randomisation 3.6. Patients in whom active treatment has been withdrawn or withdrawal is planned |
| Patient information material | |
| Anticipated start date | 01/06/2007 |
| Anticipated end date | 29/02/2012 |
| Status of trial | Ongoing |
| Target number of participants | 1006 |
| Interventions | Group 1: Conventional positive pressure ventilation Group 2: High Frequency Oscillatory Ventilation (HFOV) |
| Primary outcome measure(s) | Mortality (all causes) at day 30 |
| Secondary outcome measure(s) | 1. Mortality rate at first discharge from ICU 2. Mortality rate at first discharge from hospital 3. Mortality rate one year after randomisation 4. Non-pulmonary organ failures whilst treated on an intensive care unit 5. Health-related quality of life six months after randomisation 6. Health-related quality of life one year after randomisation 7. Pulmonary function one year after randomisation 8. Cognitive function one year after randomisation 9. In addition there are health care system outcomes: 9.1. Primary: health cost per quality-adjusted life year gained one year after randomisation 9.2. Secondary health care system benefits: Intensive care unit length of stay, hospital length of stay 10. Utilisation of hospital resources after acute hospital discharge one year after randomisation 11. Utilisation of community care resources after acute hospital discharge one year after randomisation |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Oxford University (UK) |
| Sponsor details | Clinical Trials and Research Governance Manor House John Radcliffe Hospital Headington Oxford United Kingdom OX3 9DU |
| Sponsor telephone | +44 (0)1865 743003 |
| Sponsor fax | +44 (0)1865 743002 |
| Sponsor email | heather.house@admin.ox.ac.uk |
| Sponsor website | http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml |
| Contact name | Dr J Duncan Young |
| Contact details | OSCAR Trial Office Kadoorie Centre for Critical Care Research and Education John Radcliffe Hospital Oxford United Kingdom OX3 9DU |
| Contact telephone | +44 (0)1865 220621 |
| Contact fax | +44 (0)1865 220846 |
| Contact email | OSCAR.Trial@nda.ox.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN10416500 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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