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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00529776
Other study ID # EK 38/2004
Secondary ID
Status Completed
Phase N/A
First received September 12, 2007
Last updated June 10, 2008
Start date September 2005
Est. completion date May 2008

Study information

Verified date June 2008
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date May 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

- Mechanically ventilated

- Intubated not longer than 48 h

- Medical cause for ICU admission

- Expected to be ventilated for > 48 hours

Exclusion Criteria:

- Pneumonia or ARDS present

- Postoperative patient

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Continuous lateral rotation therapy


Locations

Country Name City State
Austria Vienna General Hospital, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventilator associated pneumonia
Secondary Length of hospital stay
Secondary Length of mechanical ventilation
Secondary ICU and hospital Mortality
See also
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