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Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy
The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2003
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedNovember 6, 2014
November 1, 2014
1.5 years
September 12, 2005
November 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.
1 year
Secondary Outcomes (6)
Two weeks and three months after decannulation: Forced oscillation technique.
1 year
Three months after decannulation ENT-specialist control and MRI-scan to see whether there are signs or symptoms of tracheal stenosis.
1 year
Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure.
1 year
Post-operative complications: divided into 'complications while cannulated' and 'late complications'.
1 year
- Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.
1 year
- +1 more secondary outcomes
Study Arms (1)
subglottic drainage
ACTIVE COMPARATORsuctioning of subglottis with cannula
Interventions
Eligibility Criteria
You may qualify if:
- all patients on the intensive care unit who receive a tracheostomy.
You may not qualify if:
- HIV/AIDS
- use of immunosuppressive
- with regard to the MRI-scan patients who have a pacemaker and/or who are claustrophobic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMC st Radboud
Nijmegen, Postbus 9101, 6500 HB, Netherlands
Related Publications (1)
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.
PMID: 12879247BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
B G Fikkers, MD, PhD
Radboud University Medical Center
- PRINCIPAL INVESTIGATOR
J G van der Hoeven, MD, PhD
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Md, PhD
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
October 1, 2003
Primary Completion
April 1, 2005
Study Completion
August 1, 2005
Last Updated
November 6, 2014
Record last verified: 2014-11