Pulmonary Disease, Chronic ObstructiveNCT01021202
Timing of Dilation Tracheostomy in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Percutaneous dilation tracheostomy in people with Pulmonary Disease, Chronic Obstructive, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The purpose of this study is: to evaluate the optimal time-point for percutaneous dilation tracheostomy in COPD patients in terms of duration on mechanical ventilation, length of stay on ICU and mortality; to evaluate the rate of infections and infectious complications of tracheostomized COPD patients; to evaluate the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Percutaneous dilation tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Apr 2014
- 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
- Diagnosis of COPD (GOLD stage III or IV)
- Suspected long-time invasive mechanical ventilation due to ARF (> 10 days)
- Informed consent of the patient or legal guardian
Who cannot join
- Severe neurological failure (such as stroke, cerebral haemorrhage etc.)
- Immunosuppressant therapy (with the exception of steroid therapy)
- Major risk of bleeding
- Intubation > 72 h
- Contraindication for dilation tracheotomy
- Impossibility of intubation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Hamburg - Eppendorf (University Medical Center Hamburg-Eppendorf)
Hamburg, 20246
About this study
Official title: Early vs. Late Percutaneous Dilation Tracheostomy in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is:
- to evaluate the optimal time-point for percutaneous dilation tracheostomy in COPD patients in terms of duration on mechanical ventilation, length of stay on ICU and mortality;
- to evaluate the rate of infections and infectious complications of tracheostomized COPD patients;
- to evaluate the spectrum of pathogens in tracheostomized and intubated COPD patients;
- to evaluate the amount of sedatives used in mechanically ventilated COPD patients;
- to assess the quality of life in COPD patients tracheostomized after 3 or after 10 days.
Read the detailed description
Screening of patients following inclusion and exclusion criteria on all units of the Department of Critical Care will occur on a daily basis.
Randomization will be performed by blocks of sealed envelopes containing random numbers which are deposited at a central space within the Department of Critical Care Medicine. Randomization is performed as permuted block randomization.
Collection of baseline parameters (last/current lung function test, last/current 6-min walk test, cardiac stress test - if accessible) If not accessible, current lung function test results (at least FEV1 and FVC) are requested from the patient's general physician or pulmonologist to determine GOLD stage.
Patients randomized into the (early tracheostomy) study group, will undergo tracheostomy at the next possible opportunity but not later than 72 h after initiation of invasive ventilation. Patients of the control group will be invasively ventilated at least until Day 10.
Before tracheostomy a complete endoscopic inspection of the bronchial system will be performed routinely. Bronchoalveolar lavage fluid (BALF) will be obtained from sites of pulmonary infiltrations. In case of no radiographically or bronchoscopic detectable infiltrations BALF will be drawn from the Middle Lobe.
Primary and secondary endpoints will be analyzed at given time-points.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Percutaneous dilation tracheostomy
- Keywords
- tracheostomy, tracheotomy, dilational, dilatative, critical care, intensive care, COPD, chronic obstructive pulmonary disease, lung disease, pneumonia, prospective study, questionnaire, quality of life, outcome, mortality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous dilation tracheostomyProcedure or surgery
Percutaneous dilation tracheostomy using Ciaglia blue rhino system (Cook medical, Limerick, IRELAND). Tracheostomy is conducted by two experienced physicians with (video-)bronchoscopic control and continuous monitoring of ECG, blood pressure, pulse and peripheral oxygen saturation.
| Study group | Role | What they receive |
|---|---|---|
| Early tracheostomy | Experimental | Percutaneous dilation tracheostomy < 72h on mechanical ventilation Receives: Procedure: Percutaneous dilation tracheostomy |
| Late tracheostomy | Experimental | Percutaneous dilation tracheostomy > 10 days on mechanical ventilation Receives: Procedure: Percutaneous dilation tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative duration of mechanical ventilation (in days)
Cumulative duration of mechanical ventilation (in days)
Measured: Day 1 - 28
Secondary outcomes (5)
All-cause mortality
All-cause mortality
Measured: Day 28, 90 and end of ICU stay
Length of stay on ICU / hospital
Length of stay on ICU / hospital
Measured: end of ICU / hospital stay
Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications)
Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications)
Measured: Day 1 - 28
Cumulative use of sedatives
Cumulative use of sedatives
Measured: Day 1 - 28
Quality of Life - Questionnaire
Quality of Life - Questionnaire
Measured: discharge from ICU, day 28 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: unexpectedly slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Kluge, MD, Principal investigator, Department of Critical Care Medicine, University Medical Center Hamburg - Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021202
- Sponsor's protocol ID
- KIM-PV3278/UKE
- Status last verified
- Jun 2022
- First submitted
- 6 Oct 2009
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early vs. Late Percutaneous Dilation Tracheostomy in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01021202
- Acronym / sponsor ID
- KIM-PV3278/UKE
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- tracheostomy, tracheotomy, dilational, dilatative, critical care, intensive care, COPD, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unexpectedly slow recruitment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Nov 2009 (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 evaluate the optimal time-point for percutaneous dilation tracheostomy in COPD patients in terms of duration on mechanical ventilation, length of stay on ICU and mortality;
- to evaluate the rate of infections and infectious complications of tracheostomized COPD patients;
- to evaluate the spectrum of pathogens in tracheostomized and intubated COPD patients;
- to evaluate the amount of sedatives used in mechanically ventilated COPD patients;
- to assess the quality of life in COPD patients tracheostomized after 3 or after 10 days.
Detailed description
Screening of patients following inclusion and exclusion criteria on all units of the Department of Critical Care will occur on a daily basis.
Randomization will be performed by blocks of sealed envelopes containing random numbers which are deposited at a central space within the Department of Critical Care Medicine. Randomization is performed as permuted block randomization.
Collection of baseline parameters (last/current lung function test, last/current 6-min walk test, cardiac stress test - if accessible) If not accessible, current lung function test results (at least FEV1 and FVC) are requested from the patient's general physician or pulmonologist to determine GOLD stage.
Patients randomized into the (early tracheostomy) study group, will undergo tracheostomy at the next possible opportunity but not later than 72 h after initiation of invasive ventilation. Patients of the control group will be invasively ventilated at least until Day 10.
Before tracheostomy a complete endoscopic inspection of the bronchial system will be performed routinely. Bronchoalveolar lavage fluid (BALF) will be obtained from sites of pulmonary infiltrations. In case of no radiographically or bronchoscopic detectable infiltrations BALF will be drawn from the Middle Lobe.
Primary and secondary endpoints will be analyzed at given time-points.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early tracheostomy | Experimental | Procedure: Percutaneous dilation tracheostomyPercutaneous dilation tracheostomy < 72h on mechanical ventilation |
| Late tracheostomy | Experimental | Procedure: Percutaneous dilation tracheostomyPercutaneous dilation tracheostomy > 10 days on mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD (GOLD stage III or IV)
- Suspected long-time invasive mechanical ventilation due to ARF (> 10 days)
- Informed consent of the patient or legal guardian
Key exclusion criteria (6 listed)
- Severe neurological failure (such as stroke, cerebral haemorrhage etc.)
- Immunosuppressant therapy (with the exception of steroid therapy)
- Major risk of bleeding
- Intubation > 72 h
- Contraindication for dilation tracheotomy
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 |
|---|---|---|
| Percutaneous dilation tracheostomyPercutaneous dilation tracheostomy using Ciaglia blue rhino system (Cook medical, Limerick, IRELAND). Tracheostomy is conducted by two experienced physicians with (video-)bronchoscopic control and continuous monitoring of ECG, blood pressure, pulse and peripheral oxygen saturation. | Procedure or surgery | Early tracheostomy, Late tracheostomy |
Primary outcome
Cumulative duration of mechanical ventilation (in days)
Time frame: Day 1 - 28
Cumulative duration of mechanical ventilation (in days)
5 secondary outcomes
All-cause mortality
Time frame: Day 28, 90 and end of ICU stay
Length of stay on ICU / hospital
Time frame: end of ICU / hospital stay
Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications)
Time frame: Day 1 - 28
Cumulative use of sedatives
Time frame: Day 1 - 28
Quality of Life - Questionnaire
Time frame: discharge from ICU, day 28 and day 90
Results and safety
The study was stopped early (reason given: unexpectedly slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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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.
Stefan Kluge, MD principal investigator
Department of Critical Care Medicine, University Medical Center Hamburg - Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous dilation tracheostomy in people with Pulmonary Disease, Chronic Obstructive, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 3 inclusion and 6 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 1 Jul 2022. 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 Germany. 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: unexpectedly slow recruitment). 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?
Cumulative duration of mechanical ventilation (in days) (time frame: Day 1 - 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2022.