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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....)
Sponsor:
Information provided by (Responsible Party):
Bernard Fikkers, Radboud University
ClinicalTrials.gov Identifier:
NCT00184925
First received: September 12, 2005
Last updated: November 5, 2014
Last verified: November 2014
  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
Pneumonia
Procedure: Tracheostomy
Device: cannula with subglottic drainage

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Two weeks and three months after decannulation: Forced oscillation technique. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Post-operative complications: divided into 'complications while cannulated' and 'late complications'. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • - Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • -Late complications: complications occuring after removal of the tracheostomy tube. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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...

  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
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 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:
Responsible Party: Bernard Fikkers, Md, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT00184925     History of Changes
Other Study ID Numbers: CMO 2003/144
Study First Received: September 12, 2005
Last Updated: November 5, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on November 20, 2014