NCT00529776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 11, 2008

Status Verified

June 1, 2008

First QC Date

September 12, 2007

Last Update Submit

June 10, 2008

Conditions

Pneumonia, Ventilator-Associated

Keywords

Prevention of ventilator associated pneumonia

Outcome Measures

Primary Outcomes (1)

  • Ventilator associated pneumonia

Secondary Outcomes (3)

  • Length of hospital stay

  • Length of mechanical ventilation

  • ICU and hospital Mortality

Study Arms (2)

1

ACTIVE COMPARATOR

Continuous lateral rotation therapy

Procedure: Continuous lateral rotation therapy

2

NO INTERVENTION

Standard manual positioning (Supine position)

Interventions

Continuous lateral rotation therapyPROCEDURE
1

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanically ventilated
  • Intubated not longer than 48 h
  • Medical cause for ICU admission
  • Expected to be ventilated for \> 48 hours

You may not qualify if:

  • Pneumonia or ARDS present
  • Postoperative patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna General Hospital, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 14, 2007

Study Start

September 1, 2005

Study Completion

May 1, 2008

Last Updated

June 11, 2008

Record last verified: 2008-06

Locations

AU(1)