Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
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)
Study design
Randomised, controlled, single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/06/2004
Overall trial end date
30/09/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 patients
Participant 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
Recruitment start date
01/06/2004
Recruitment end date
30/09/2006
Locations
Countries of recruitment
Korea, South
Trial participating centre
Division of Pulmonary and Critical Care Medicine
Seoul
138-736
Korea, South
Sponsor information
Organisation
Asan Medical Center (South Korea)
Sponsor details
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
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Asan Medical Center (South Korea) - the internal research fund of Intensive Care Units
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19239703
Publication citations
-
Results
Huh JW, Jung H, Choi HS, Hong SB, Lim CM, Koh Y, Efficacy of positive end-expiratory pressure titration after the alveolar recruitment manoeuvre in patients with acute respiratory distress syndrome., Crit Care, 2009, 13, 1, R22, doi: 10.1186/cc7725.