Back to resultsVentilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy
Primary Purpose
Pneumonia
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Tracheostomy
cannula with subglottic drainage
Sponsored by
About this trial
This is an interventional prevention trial for Pneumonia
Eligibility 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
Sites / Locations
- UMC st Radboud
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
subglottic drainage
Arm Description
suctioning of subglottis with cannula
Outcomes
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.
Full Information
NCT ID
NCT00184925
First Posted
September 12, 2005
Last Updated
November 5, 2014
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00184925
Brief Title
Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy
Official Title
The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Analysis was frustrated by inadequate PhD's....
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This study did not generate the expectations's we've expected, therefore, the analysis was prematurely stopped...
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subglottic drainage
Arm Type
Active Comparator
Arm Description
suctioning of subglottis with cannula
Intervention Type
Procedure
Intervention Name(s)
Tracheostomy
Intervention Description
trachesotomy with subglottic drainage
Intervention Type
Device
Intervention Name(s)
cannula with subglottic drainage
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Two weeks and three months after decannulation: Forced oscillation technique.
Time Frame
1 year
Title
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
Title
Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure.
Time Frame
1 year
Title
Post-operative complications: divided into 'complications while cannulated' and 'late complications'.
Time Frame
1 year
Title
- Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.
Time Frame
1 year
Title
-Late complications: complications occuring after removal of the tracheostomy tube.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B G Fikkers, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J G van der Hoeven, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC st Radboud
City
Nijmegen
State/Province
Postbus 9101
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
12879247
Citation
Fikkers BG, Fransen GA, van der Hoeven JG, Briede IS, van den Hoogen FJ. Tracheostomy for long-term ventilated patients: a postal survey of ICU practice in The Netherlands. Intensive Care Med. 2003 Aug;29(8):1390-3. doi: 10.1007/s00134-003-1824-x. Epub 2003 Jul 22.
Results Reference
background
Learn more about this trial
Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy
We'll reach out to this number within 24 hrs