Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy

June 10, 2008 updated by: Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Vienna General Hospital, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Continuous lateral rotation therapy
Procedure: Continuous lateral rotation therapy
No Intervention: 2
Standard manual positioning (Supine position)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ventilator associated pneumonia

Secondary Outcome Measures

Outcome Measure
Length of hospital stay
Length of mechanical ventilation
ICU and hospital Mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Thomas Staudinger, MD, Department of Internal Medicine I, Medical University of Vienna, Austria
  • Principal Investigator: Thomas Staudinger, MD, Dept. of Internal Medicine I, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 12, 2007

First Submitted That Met QC Criteria

September 12, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

June 11, 2008

Last Update Submitted That Met QC Criteria

June 10, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 38/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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