Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2007 by Radboud University.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Radboud University

ClinicalTrials.gov Identifier:

NCT00184925

First received: September 12, 2005

Last updated: July 30, 2007

Last verified: July 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

July 30, 2007

Start Date ^ICMJE

October 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00184925 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

Official Title ^ICMJE

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

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Tracheostomy
Pneumonia

Intervention ^ICMJE

Procedure: Tracheostomy
Device: cannula with subglottic drainage

Study Arm (s)

Not Provided

Publications *

Fikkers BG, Fransen GA, van der Hoeven JG, Briede IS, van den Hoogen FJ. Tracheostomy for long-term ventilated patients: a postal survey of ICU practice in The Netherlands. Intensive Care Med. 2003 Aug;29(8):1390-3. Epub 2003 Jul 22.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

120

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00184925

Other Study ID Numbers ^ICMJE

CMO 2003/144

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Radboud University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	B G Fikkers, MD, PhD	Radboud University
Principal Investigator:	J G van der Hoeven, MD, PhD	Radboud University

Information Provided By

Radboud University

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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