Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

Not Applicable

Terminated

• Conditions: Pneumonia
• Interventions: Procedure: Tracheostomy; Device: cannula with subglottic drainage

• Registration Number: NCT00184925
• Lead Sponsor: Radboud University Medical Center

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...

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2005-04
• Study Completion: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
subglottic drainage	Tracheostomy	suctioning of subglottis with cannula
subglottic drainage	cannula with subglottic drainage	suctioning of subglottis with cannula

Primary Outcome Measures

Name	Time	Method
Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.	1 year

Secondary Outcome Measures

Name	Time	Method
-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

Trial Locations

Locations (1)

UMC st Radboud; 🇳🇱 Nijmegen, Postbus 9101, Netherlands