Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

November 5, 2014 updated by: Bernard Fikkers, Radboud University Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Postbus 9101
      • Nijmegen, Postbus 9101, Netherlands, 6500 HB
        • UMC St Radboud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: subglottic drainage
suctioning of subglottis with cannula
Procedure: Tracheostomy
trachesotomy with subglottic drainage
Device: cannula with subglottic drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMO 2003/144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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