Efficacy of positive end-expiratory pressure titration after the alveolar recruitment manoeuvre in patients with acute respiratory distress syndrome
| ISRCTN | ISRCTN79027921 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79027921 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/10/2008
- Registration date
- 31/10/2008
- Last edited
- 12/03/2010
- 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
Prof Younsuck Koh
Scientific
Scientific
Division of Pulmonary and Critical Care Medicine
Asan Medical Center
College of Medicine
University of Ulsan
388-1 Pungnap-dong
Songpa-gu
Seoul
138-736
Korea, South
Study information
| Study design | Randomised, controlled, single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | In the acute respiratory distress syndrome (ARDS), the right level of positive end-expiratory pressure (PEEP) may decrease ventilator-induced lung injury by opening the lung and keeping it open. We evaluated whether setting the PEEP using decremental PEEP titration after alveolar recruitment manoeuvre (ARM) affects the clinical outcome in patients with ARDS. |
| Ethics approval(s) | The study protocol was approved by the Institutional Board of the Ethics Committee of Asan Medical Center on the 14th August 2006 (ref: 2006-0286) |
| Health condition(s) or problem(s) studied | Acute respiratory distress syndrome (ARDS) |
| Intervention | Control group: The FiO2-PEEP strategy has been used in previous ARDS Network studies. PEEP and FiO2 were set according to the table of lower PEEP/higher FiO2 combinations, with the goal of obtaining a lower PEEP level compatible with an oxygenation target. Decremental PEEP titration group: The alveolar recruitment manoeuvre (ARM) was performed immediately after enrolment in the study and was applied once a day in the morning for 1 week. After ARM, the decrease in PEEP was continued until a decrease of greater than 2% of the saturation from the previous SaO2 and drop of static compliance was identified (decremental PEEP titration). Total duration of treatment: 1 week Total duration of follow-up: from enrolment to leaving the hospital |
| Intervention type | Other |
| Primary outcome measure | 28-day mortality |
| Secondary outcome measures | 1. Duration of mechanical ventilation 2. Intensive Care Unit (ICU) stay 3. Use of paralysing or sedative agents Measured until leaving the hospital. |
| Overall study start date | 01/06/2004 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 patients |
| Key inclusion criteria | 1. Criteria of ARDS proposed by the American-European Consensus Conference: 1.1. Acute onset 1.2. Presence of hypoxaemia (arterial oxygen tension/fraction of inspired oxygen (FiO2) (PF ratio) less than 200 mmHg regardless of the PEEP level) 1.3. Bilateral and diffuse opacities seen on frontal chest X-ray film 1.4. Absence of left ventricular failure with pulmonary arterial occluded pressure less than 18 mmHg 2. Recruited into the trial within 48 hours of meeting above ARDS criteria 3. Aged 18 - 82 years, either sex |
| Key exclusion criteria | 1. Haemodynamic instability 2. Elevated intracranial pressure 3. High risk of mortality within 3 months from other than ARDS (severe organ failure, and cancer patients in terminal stages of the disease) 4. Refusal to participate |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Division of Pulmonary and Critical Care Medicine
Seoul
138-736
Korea, South
138-736
Korea, South
Sponsor information
Asan Medical Center (South Korea)
Hospital/treatment centre
Hospital/treatment centre
c/o Younsuck Koh
Division of Pulmonary and Critical Care Medicine
College of Medicine
University of Ulsan
388-1 Pungnap-dong
Songpa-gu
Seoul
138-736
Korea, South
| Website | http://www1.amc.seoul.kr |
|---|---|
"ROR" |
https://ror.org/03s5q0090 |
Funders
Funder type
Hospital/treatment centre
Asan Medical Center (South Korea) - the internal research fund of Intensive Care Units
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 | 01/12/2009 | Yes | No |
