Acute respiratory distress syndrome Respiratory Acute respiratory distress syndrome
Conditions
Interventions
Participants are randomly allocated to one of two groups:
Group 1: Conventional positive pressure ventilation
Group 2: High Frequency Oscillatory Ventilation (HFOV)
Sponsors
Oxford University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 16 years and over 2. Weight 35 kg and over 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
Exclusion criteria
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 Patients in whom active treatment has been withdrawn or withdrawal is planned
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality (all causes) at day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed