CClinicalTrials.gg
TerminatedNCT00184925Updated Nov 6, 2014

Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

An interventional study of Tracheostomy and cannula with subglottic drainage in Pneumonia, sponsored by Radboud University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-06.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Prevention

Why this study was terminated
Analysis was frustrated by inadequate PhD's....
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 120 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • all patients on the intensive care unit who receive a tracheostomy.

Exclusion criteria

Exclusion Criteria:

  • HIV/AIDS
  • use of immunosuppressive
  • with regard to the MRI-scan patients who have a pacemaker and/or who are claustrophobic
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    subglottic drainage

    suctioning of subglottis with cannula

    Procedure: Tracheostomy · Device: cannula with subglottic drainage

Interventions

  • ProcedureTracheostomy

    trachesotomy with subglottic drainage

  • Devicecannula with subglottic drainage
06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Two weeks and three months after decannulation: Forced oscillation technique.

    Time frame: 1 year

  2. 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

  3. Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure.

    Time frame: 1 year

  4. Post-operative complications: divided into 'complications while cannulated' and 'late complications'.

    Time frame: 1 year

  5. - Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.

    Time frame: 1 year

  6. -Late complications: complications occuring after removal of the tracheostomy tube.

    Time frame: 1 year

07

Study locations

1 site
  • UMC st Radboud
    Nijmegen, Postbus 9101 6500 HB, Netherlands
08

References and documents

Publications

  • 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. PubMed 12879247 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00184925
Lead sponsor
Radboud University Medical Center
Responsible party
Bernard Fikkers (Md, PhD, Radboud University Medical Center) — Principal investigator
First posted
Sep 16, 2005
Start date
Oct 2003
Primary completion
Apr 2005
Completion
Aug 2005
Last update
Nov 6, 2014

Study contacts

B G Fikkers, MD, PhD
principal investigator · Radboud University Medical Center
J G van der Hoeven, MD, PhD
principal investigator · Radboud University Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion