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Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

This study has been terminated.
(Analysis was frustrated by inadequate PhD's....)
Information provided by (Responsible Party):
Bernard Fikkers, Radboud University Identifier:
First received: September 12, 2005
Last updated: November 5, 2014
Last verified: November 2014
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
Pneumonia Procedure: Tracheostomy Device: cannula with subglottic drainage

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques

Resource links provided by NLM:

Further study details as provided by Bernard Fikkers, Radboud University:

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

Secondary Outcome Measures:
  • Two weeks and three months after decannulation: Forced oscillation technique. [ Time Frame: 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 ]
  • Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure. [ Time Frame: 1 year ]
  • Post-operative complications: divided into 'complications while cannulated' and 'late complications'. [ Time Frame: 1 year ]
  • - Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube. [ Time Frame: 1 year ]
  • -Late complications: complications occuring after removal of the tracheostomy tube. [ Time Frame: 1 year ]

Enrollment: 120
Study Start Date: October 2003
Study Completion Date: August 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: subglottic drainage
suctioning of subglottis with cannula
Procedure: Tracheostomy
trachesotomy with subglottic drainage
Device: cannula with subglottic drainage

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00184925

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

Responsible Party: Bernard Fikkers, Md, PhD, Radboud University Identifier: NCT00184925     History of Changes
Other Study ID Numbers: CMO 2003/144
Study First Received: September 12, 2005
Last Updated: November 5, 2014

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury processed this record on August 18, 2017