Randomised prospective European Multicenter Oscillator Acute Respiratory Distress Syndrome (ARDS) Trial
| ISRCTN | ISRCTN24242669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24242669 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/11/2004
- Registration date
- 12/05/2005
- Last edited
- 13/03/2020
- 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
Not provided at time of registration
Contact information
Prof Adrianus Van Vught
Scientific
Scientific
P.O. Box 85090
Utrecht
3508 AB
Netherlands
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Randomised prospective European Multicenter Oscillator Acute Respiratory Distress Syndrome (ARDS) Trial |
| Study acronym | EMOAT - European Multicenter Oscillator ARDS Trial |
| Study hypothesis | To compare the safety and efficacy of high frequency oscillatory ventilation (HFOV) with conventional mechanical ventilation (CMV) for early intervention in adult respiratory distress syndrome (ARDS). |
| Ethics approval(s) | This study was approved by the ethical committee board of all participating institutions and was in compliance with the Helsinki Declaration. |
| Condition | Acute respiratory distress syndrome (ARDS) |
| Intervention | High frequency oscillatory ventilation (HFOV) compared with conventional mechanical ventilation (CMV). |
| Intervention type | Other |
| Primary outcome measure | 1. Cumulative survival without mechanical ventilation or oxygen dependency at 30 days 2. Mortality at 30 days |
| Secondary outcome measures | 1. Therapy failure 2. Crossover rate 3. Persisting pulmonary problems defined as oxygen dependency or still being on a ventilator at 30 days |
| Overall study start date | 01/10/1997 |
| Overall study end date | 31/03/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 61 |
| Participant inclusion criteria | 1. Patients with ARDS, defined as: 1.1. The pressure of arterial oxygen divided by the fraction of inspired oxygen (paO2/FiO2) less than 200 mmHg 1.2. Radiographic evidence of bilateral infiltrates on chest X-ray 1.3. No evidence of atrial hypertension 2. Body weight greater than 35 kg |
| Participant exclusion criteria | 1. Non-pulmonary terminal disease 2. Severe chronic obstructive pulmonary disease 3. Asthma and grade 3 or 4 air-leak 4. FiO2 greater than 0.80 for 48 hours 5. More than 10 days of mechanical ventilation |
| Recruitment start date | 01/10/1997 |
| Recruitment end date | 31/03/2001 |
Locations
Countries of recruitment
- France
- Germany
- Netherlands
- United Kingdom
Study participating centre
P.O. Box 85090
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Sponsor information
SensorMedics (USA)
Industry
Industry
22705 Savi Ranch Parkway
Yorba Linda
CA 92687
United States of America
"ROR" |
https://ror.org/03x1ewr52 |
|---|
Funders
Funder type
Industry
SensorMedics (USA)
No information available
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 | 01/08/2005 | Yes | No |
Editorial Notes
13/03/2020: Internal review.
