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Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

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ClinicalTrials.gov Identifier: NCT00184925
Recruitment Status : Terminated (Analysis was frustrated by inadequate PhD's....)
First Posted : September 16, 2005
Last Update Posted : November 6, 2014
Sponsor:
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...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
U.S. FDA Resources

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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Bernard Fikkers, Md, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT00184925     History of Changes
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:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury