Tracheal Stenosis Following TracheostomyNCT05924087
Interventional Therapy of Tracheal Stenosis
An observational study of Tracheal Stenosis Following Tracheostomy, run by Asklepios Neurological Clinic Bad Salzhausen at 1 site in Germany.
Trial summary
After respiratory weaning, decannulation is sought. To do this, the tracheal cannula is first unblocked, so that patients no longer breathe in and out through the cannula, but (at least partially) "passing" the cannula by the natural route. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Stenosis Following Tracheostomy
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2023to 31 Jul 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
Study population: Patients after successfull respiratory weaning with symptomatic trachealstenosis
Who may be able to join
- Tracheal stenosis after percutaneous tracheotomy.
Who cannot join
- Pregnant or breast-feeding women of childbearing potential who refuse pregnancy test.
- lack of consent to participate in the study.
- surgical tracheotomy.
- Involvement of the larynx (above the first tracheal brace).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Neurologische Klinik Bad Salzhausen
Nidda, 63667
Dirk Bandorski, MD, PhD, +496043804212, d.bandorski@asklepios.com
Pascal Klingenberger, MD, p.klingenberger@asklepios.com
About this study
Official title: Interventional Therapy of Tracheal Stenosis After Percutaneous Tracheotomia
After respiratory weaning, decannulation is sought. To do this, the tracheal cannula is first unblocked, so that patients no longer breathe in and out through the cannula, but (at least partially) "passing" the cannula by the natural route. In the presence of tracheal stenosis there is increased breathing effort, possibly restlessness and stridor. This constellation of symptoms suggests the suspicion of tracheal stenosis, so in the next step a tracheoscopy is performed to confirm or exclude tracheal stenosis. In case of symptomatic tracheal stenosis and at least 30-50% stenosis of the trachea (clinical symptoms can be expected from a 30-50% stenosis) then appropriate therapy (here: cryotherapy, other techniques only in exceptional cases) is planned. The goal is to be able to remove the tracheal cannula (long term) after successful therapy, so that patients do not have to be permanently provided with a tracheal cannula. There is no definitive/evidence-based standard therapy for the treatment of tracheal stenosis. Cryotherapy is a gentle therapy that has already been applied and described for the treatment of tracheal stenosis (see above). The examination is performed as part of an analgesic dose, as is routine for a bronchoscopy (in-house SOP). After treatment, a follow-up is planned for about 10 days later.
- Conditions
- Tracheal Stenosis Following Tracheostomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Decannulation
Rate of successful decannulations after intervention up to discharge from inpatient treatment.
Measured: 12 months
Secondary outcomes (5)
Technical success
technical success of the intervention (endoscopically not clinically relevant tracheal stenosis).
Measured: 12 months
Reintervention(s)
Number of interventions required.
Measured: 12 months
Type of intervention
Type of intervention(s) (cyroablation, APC, loop extraction).
Measured: 12 months
Clinical success
Clinical success (no stridor, no dyspnoea).
Measured: 12 months
Additional treatment
Number of patients requiring surgical treatment/stent.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal Stenosis Following TracheostomyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Asklepios Neurological Clinic Bad Salzhausen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924087
- Sponsor's protocol ID
- ITTS10_06_2023
- Status last verified
- Jul 2024
- First submitted
- 10 Jun 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Therapy of Tracheal Stenosis After Percutaneous Tracheotomia
- ClinicalTrials.gov ID
- NCT05924087
- Acronym / sponsor ID
- ITTS10_06_2023
- Conditions
- Tracheal Stenosis Following Tracheostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Asklepios Neurological Clinic Bad SalzhausenUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 29 Jun 2023 (actual)
- 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.
After respiratory weaning, decannulation is sought. To do this, the tracheal cannula is first unblocked, so that patients no longer breathe in and out through the cannula, but (at least partially) "passing" the cannula by the natural route. In the presence of tracheal stenosis there is increased breathing effort, possibly restlessness and stridor. This constellation of symptoms suggests the suspicion of tracheal stenosis, so in the next step a tracheoscopy is performed to confirm or exclude tracheal stenosis. In case of symptomatic tracheal stenosis and at least 30-50% stenosis of the trachea (clinical symptoms can be expected from a 30-50% stenosis) then appropriate therapy (here: cryotherapy, other techniques only in exceptional cases) is planned. The goal is to be able to remove the tracheal cannula (long term) after successful therapy, so that patients do not have to be permanently provided with a tracheal cannula. There is no definitive/evidence-based standard therapy for the treatment of tracheal stenosis. Cryotherapy is a gentle therapy that has already been applied and described for the treatment of tracheal stenosis (see above). The examination is performed as part of an analgesic dose, as is routine for a bronchoscopy (in-house SOP). After treatment, a follow-up is planned for about 10 days later.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after successfull respiratory weaning with symptomatic trachealstenosis
Key inclusion criteria (1 listed)
- Tracheal stenosis after percutaneous tracheotomy.
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding women of childbearing potential who refuse pregnancy test.
- lack of consent to participate in the study.
- surgical tracheotomy.
- Involvement of the larynx (above the first tracheal brace).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decannulation
Time frame: 12 months
Rate of successful decannulations after intervention up to discharge from inpatient treatment.
5 secondary outcomes
Technical success
Time frame: 12 months
Reintervention(s)
Time frame: 12 months
Type of intervention
Time frame: 12 months
Clinical success
Time frame: 12 months
Additional treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Stenosis Following Tracheostomy, run by Asklepios Neurological Clinic Bad Salzhausen 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decannulation (time frame: 12 months). 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 31 Jul 2024.