PneumoniaNCT00184925
Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy
A study testing Tracheostomy and cannula with subglottic drainage in people with Pneumonia, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Tracheostomy and cannula with subglottic drainage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2003to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients on the intensive care unit who receive a tracheostomy.
Who cannot join
- HIV/AIDS
- use of immunosuppressive
- with regard to the MRI-scan patients who have a pacemaker and/or who are claustrophobic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques
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...
- Conditions
- Pneumonia
- Being tested
- Tracheostomy, cannula with subglottic drainage
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheostomyProcedure or surgery
trachesotomy with subglottic drainage
cannula with subglottic drainageDevice
| Study group | Role | What they receive |
|---|---|---|
| subglottic drainage | Active comparator | suctioning of subglottis with cannula Receives: Procedure: Tracheostomy; Device: cannula with subglottic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.
Measured: 1 year
Secondary outcomes (6)
Two weeks and three months after decannulation: Forced oscillation technique.
Measured: 1 year
Three months after decannulation ENT-specialist control and MRI-scan to see whether there are signs or symptoms of tracheal stenosis.
Measured: 1 year
Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure.
Measured: 1 year
Post-operative complications: divided into 'complications while cannulated' and 'late complications'.
Measured: 1 year
- Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.
Measured: 1 year
-Late complications: complications occuring after removal of the tracheostomy tube.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionApr 2005
- Study completionAug 2005
Why it stopped: Analysis was frustrated by inadequate PhD's....
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Fikkers, Radboud University Medical Center
- Investigators
- B G Fikkers, MD, PhD, Principal investigator, Radboud University Medical CenterJ G van der Hoeven, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184925
- Sponsor's protocol ID
- CMO 2003/144
- Status last verified
- Nov 2014
- First submitted
- 12 Sep 2005
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques
- ClinicalTrials.gov ID
- NCT00184925
- Acronym / sponsor ID
- CMO 2003/144
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Analysis was frustrated by inadequate PhD's....
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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...
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subglottic drainage | Active comparator | Procedure: Tracheostomy, Device: cannula with subglottic drainagesuctioning of subglottis with cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients on the intensive care unit who receive a tracheostomy.
Key exclusion criteria (3 listed)
- HIV/AIDS
- use of immunosuppressive
- with regard to the MRI-scan patients who have a pacemaker and/or who are claustrophobic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracheostomytrachesotomy with subglottic drainage | Procedure or surgery | subglottic drainage |
| cannula with subglottic drainage | Device | subglottic drainage |
Primary outcome
Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.
Time frame: 1 year
6 secondary outcomes
Two weeks and three months after decannulation: Forced oscillation technique.
Time frame: 1 year
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
Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure.
Time frame: 1 year
Post-operative complications: divided into 'complications while cannulated' and 'late complications'.
Time frame: 1 year
- Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.
Time frame: 1 year
-Late complications: complications occuring after removal of the tracheostomy tube.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Analysis was frustrated by inadequate PhD's....). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Background: PubMed 12879247Fikkers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B G Fikkers, MD, PhD principal investigator
Radboud University Medical Center
J G van der Hoeven, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheostomy and cannula with subglottic drainage in people with Pneumonia, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Analysis was frustrated by inadequate PhD's....). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.