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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00184925
Enrollment
120
Registered
2005-09-16
Start date
2003-10-31
Completion date
2005-08-31
Last updated
2014-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

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...

Interventions

PROCEDURETracheostomy

trachesotomy with subglottic drainage

DEVICEcannula with subglottic drainage

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.1 year

Secondary

MeasureTime frame
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
Two weeks and three months after decannulation: Forced oscillation technique.1 year
- Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.1 year
-Late complications: complications occuring after removal of the tracheostomy tube.1 year
Post-operative complications: divided into 'complications while cannulated' and 'late complications'.1 year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026