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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
  Purpose

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.


Condition Intervention
Tracheostomy
Pneumonia
 Procedure: Tracheostomy
Device: cannula with subglottic drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: October 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184925

Locations
Netherlands
UMC st Radboud
Nijmegen, Postbus 9101, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: B G Fikkers, MD, PhD Radboud University
Principal Investigator: J G van der Hoeven, MD, PhD Radboud University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00184925     History of Changes
Other Study ID Numbers: CMO 2003/144
Study First Received: September 12, 2005
Last Updated: July 30, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on May 19, 2013