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Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy

Primary Purpose

Pneumonia, Ventilator-Associated

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Continuous lateral rotation therapy
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia, Ventilator-Associated focused on measuring Prevention of ventilator associated pneumonia

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vienna General Hospital, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Continuous lateral rotation therapy

Standard manual positioning (Supine position)

Outcomes

Primary Outcome Measures

Ventilator associated pneumonia

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2007
Last Updated
June 10, 2008
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00529776
Brief Title
Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy
Official Title
Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-Associated
Keywords
Prevention of ventilator associated pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Continuous lateral rotation therapy
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard manual positioning (Supine position)
Intervention Type
Procedure
Intervention Name(s)
Continuous lateral rotation therapy
Primary Outcome Measure Information:
Title
Ventilator associated pneumonia
Secondary Outcome Measure Information:
Title
Length of hospital stay
Title
Length of mechanical ventilation
Title
ICU and hospital Mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Staudinger, MD
Organizational Affiliation
Department of Internal Medicine I, Medical University of Vienna, Austria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Staudinger, MD
Organizational Affiliation
Dept. of Internal Medicine I, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna General Hospital, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy

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