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Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184925
Recruitment Status : Terminated (Analysis was frustrated by inadequate PhD's....)
First Posted : September 16, 2005
Last Update Posted : November 6, 2014
Information provided by (Responsible Party):
Bernard Fikkers, Radboud University

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.

Condition or disease Intervention/treatment Phase
Pneumonia Procedure: Tracheostomy Device: cannula with subglottic drainage Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
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
Study Start Date : October 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Active Comparator: subglottic drainage
suctioning of subglottis with cannula
Procedure: Tracheostomy
trachesotomy with subglottic drainage

Device: cannula with subglottic drainage

Primary Outcome Measures :
  1. 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 :
  1. Two weeks and three months after decannulation: Forced oscillation technique. [ Time Frame: 1 year ]
  2. 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 ]
  3. Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure. [ Time Frame: 1 year ]
  4. Post-operative complications: divided into 'complications while cannulated' and 'late complications'. [ Time Frame: 1 year ]
  5. - Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube. [ Time Frame: 1 year ]
  6. -Late complications: complications occuring after removal of the tracheostomy tube. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00184925

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UMC st Radboud
Nijmegen, Postbus 9101, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
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Principal Investigator: B G Fikkers, MD, PhD Radboud University
Principal Investigator: J G van der Hoeven, MD, PhD Radboud University
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Responsible Party: Bernard Fikkers, Md, PhD, Radboud University Identifier: NCT00184925    
Other Study ID Numbers: CMO 2003/144
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection