Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

Pneumonia Clinical Trial

Official title:

The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00184925
• Other study ID #: CMO 2003/144
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 5, 2014
• Start date: October 2003
• Est. completion date: August 2005

Study information

• Verified date: November 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

This study did not generate the expectations's we've expected, therefore, the analysis was prematurely stopped...

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: August 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

Procedure:
• Tracheostomy
trachesotomy with subglottic drainage

Device:
• cannula with subglottic drainage

Locations

Country	Name	City	State
Netherlands	UMC st Radboud	Nijmegen	Postbus 9101

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Fikkers BG, Fransen GA, van der Hoeven JG, Briedé 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. Epub 2003 Jul 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.		1 year	No
Secondary	Two weeks and three months after decannulation: Forced oscillation technique.		1 year	No
Secondary	Three months after decannulation ENT-specialist control and MRI-scan to see whether there are signs or symptoms of tracheal stenosis.		1 year	No
Secondary	Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure.		1 year	No
Secondary	Post-operative complications: divided into 'complications while cannulated' and 'late complications'.		1 year	No
Secondary	- Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.		1 year	No
Secondary	-Late complications: complications occuring after removal of the tracheostomy tube.		1 year	No