Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

NCT ID: NCT00184925

Last Updated: 2014-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-08-31

Brief Summary

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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

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

Conditions

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Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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subglottic drainage

suctioning of subglottis with cannula

Group Type ACTIVE_COMPARATOR

Tracheostomy

Intervention Type PROCEDURE

trachesotomy with subglottic drainage

cannula with subglottic drainage

Intervention Type DEVICE

Interventions

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Tracheostomy

trachesotomy with subglottic drainage

Intervention Type PROCEDURE

cannula with subglottic drainage

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Bernard Fikkers

Md, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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B G Fikkers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

J G van der Hoeven, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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UMC st Radboud

Nijmegen, Postbus 9101, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 12879247 (View on PubMed)

Other Identifiers

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CMO 2003/144

Identifier Type: -

Identifier Source: org_study_id

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