Condition category
Respiratory
Date applied
13/06/2005
Date assigned
14/06/2005
Last edited
30/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chieh-Liang Wu

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRBTCVGH910911

Study information

Scientific title

Acronym

Study hypothesis

To 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Severe community-acquired pneumonia with ARDS

Intervention

Continuous prone position ventilation for 72 hours versus supine position

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

1. Plasma cytokine levels
2. Mortality

Overall trial start date

01/09/2002

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Severe community-acquired pneumonia with ARDS

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15 prone and 15 supine

Participant exclusion criteria

Home 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.

Recruitment start date

01/09/2002

Recruitment end date

31/12/2003

Locations

Countries of recruitment

Taiwan

Trial participating centre

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

Sponsor information

Organisation

Taichung Veterans General Hospital (Taiwan)

Sponsor details

No. 160
Sec. 3
Chung-Kang Rd.
Taichung
407
Taiwan

Sponsor type

Hospital/treatment centre

Website

http://www.vghtc.gov.tw

Funders

Funder type

Hospital/treatment centre

Funder name

Taichung Veterans General Hospital (Taiwan)

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17908660

Publication citations

  1. Results

    Chan MC, Hsu JY, Liu HH, Lee YL, Pong SC, Chang LY, Kuo BI, Wu CL, Effects of prone position on inflammatory markers in patients with ARDS due to community-acquired pneumonia., J. Formos. Med. Assoc., 2007, 106, 9, 708-716, doi: 10.1016/S0929-6646(08)60032-7.

Additional files

Editorial Notes