Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy

This study has been completed.
Sponsor:
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
  Purpose

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.


Condition Intervention
Pneumonia, Ventilator-Associated
Procedure: Continuous lateral rotation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Ventilator associated pneumonia

Secondary Outcome Measures:
  • Length of hospital stay
  • Length of mechanical ventilation
  • ICU and hospital Mortality

Enrollment: 150
Study Start Date: September 2005
Study Completion Date: May 2008
Arms Assigned Interventions
Active Comparator: 1
Continuous lateral rotation therapy
Procedure: Continuous lateral rotation therapy
No Intervention: 2
Standard manual positioning (Supine position)

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529776

Locations
Austria
Vienna General Hospital, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Thomas Staudinger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00529776     History of Changes
Other Study ID Numbers: EK 38/2004
Study First Received: September 12, 2007
Last Updated: June 10, 2008
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:
Prevention of ventilator associated pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Cross Infection
Infection
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on November 24, 2014