The influence of prolonged prone position ventilation in patients of acute respiratory distress syndrome (ARDS) due to severe community-acquired pneumonia

ISRCTN ISRCTN46247055
DOI https://doi.org/10.1186/ISRCTN46247055
Protocol serial number IRBTCVGH910911
Sponsor Taichung Veterans General Hospital (Taiwan)
Funder Taichung Veterans General Hospital (Taiwan)
Submission date
13/06/2005
Registration date
14/06/2005
Last edited
30/10/2008
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

Dr Chieh-Liang Wu
Scientific

No. 160, Sec. 3, Chung-Kang Rd.
Taichung
40705
Taiwan

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo test if prolonged prone position ventilation can improve oxygenation in patients with severe community-acquired pneumonia. We also evaluate the associated complications due to this maneuver and plasma cytokine level change.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSevere community-acquired pneumonia with ARDS
InterventionContinuous prone position ventilation for 72 hours versus supine position
Intervention typeOther
Primary outcome measure(s)

1. Improvement of oxygenation
2. Complications associated with prolonged position ventilation

Key secondary outcome measure(s)

1. Plasma cytokine levels
2. Mortality

Completion date31/12/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration30
Key inclusion criteriaSevere community-acquired pneumonia with ARDS
Key exclusion criteriaHome oxygen use needed, pulmonary tuberculosis, malignancy under chemotherapy, acquired immunodeficiency syndrome (AIDS), organ transplant or autoimmune disease under immunosuppressant therapy, bone fracture and spine instability.
Date of first enrolment01/09/2002
Date of final enrolment31/12/2003

Locations

Countries of recruitment

  • Taiwan

Study participating centre

No. 160, Sec. 3, Chung-Kang Rd.
Taichung
40705
Taiwan

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2007 Yes No