Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy
This study has been completed.
Sponsor:
Medical University of Vienna
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00529776
First received: September 12, 2007
Last updated: June 10, 2008
Last verified: June 2008
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2007 | ||||||||
| Last Updated Date | June 10, 2008 | ||||||||
| Start Date ICMJE | September 2005 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Ventilator associated pneumonia | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00529776 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy | ||||||||
| Official Title ICMJE | Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy | ||||||||
| Brief Summary | Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds. Patients are randomized to CLRT or supine position if mechanically ventilated and not suffering from pneumonia or ARDS within 48 hours after intubation. Prophylaxis of VAP is standardized in both groups. Primary endpoint is incidence of VAP, secondary endpoints are length of ventilation, length of stay and mortality. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
||||||||
| Condition ICMJE | Pneumonia, Ventilator-Associated | ||||||||
| Intervention ICMJE | Procedure: Continuous lateral rotation therapy | ||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 150 | ||||||||
| Completion Date | May 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 89 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00529776 | ||||||||
| Other Study ID Numbers ICMJE | EK 38/2004 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Thomas Staudinger, Medical University of Vienna | ||||||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Medical University of Vienna | ||||||||
| Verification Date | June 2008 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||