The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques

Radboud University Medical Center1 site in 1 country120 target enrollmentOctober 2003

ConditionsPneumonia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pneumonia
Sponsor: Radboud University Medical Center
Enrollment: 120
Locations: 1
Primary Endpoint: Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the incidence of ventilator associated pneumonia and late complications by comparing two different cannulas and two different percutaneous tracheostomy techniques.

Detailed Description

This study did not generate the expectations's we've expected, therefore, the analysis was prematurely stopped...

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

August 2005

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Radboud University Medical Center

Responsible Party

Principal Investigator

Bernard Fikkers

Md, PhD

Radboud University Medical Center

Eligibility Criteria

Inclusion Criteria

•all patients on the intensive care unit who receive a tracheostomy.

Exclusion Criteria

•use of immunosuppressive
•with regard to the MRI-scan patients who have a pacemaker and/or who are claustrophobic

Outcomes

Primary Outcomes

Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.

Time Frame: 1 year

Secondary Outcomes

-Late complications: complications occuring after removal of the tracheostomy tube.(1 year)
Two weeks and three months after decannulation: Forced oscillation technique.(1 year)
Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure.(1 year)
Three months after decannulation ENT-specialist control and MRI-scan to see whether there are signs or symptoms of tracheal stenosis.(1 year)
Post-operative complications: divided into 'complications while cannulated' and 'late complications'.(1 year)
- Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.(1 year)