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RecruitingNCT05924087Updated Jul 31, 2024

Interventional Therapy of Tracheal Stenosis

An observational study in Tracheal Stenosis Following Tracheostomy, sponsored by Asklepios Neurological Clinic Bad Salzhausen. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Asklepios Neurological Clinic Bad Salzhausen · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Tracheal Stenosis Following Tracheostomy
03

In context

Tracheal Stenosis

37 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.

This study's planned enrollment of 250 is above the median of 78 across 12 observational studies indexed under Tracheal Stenosis.

Browse Tracheal Stenosis studies →

Lead sponsor

Asklepios Neurological Clinic Bad Salzhausen is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

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
Sampling method
Probability sample

Study population

Patients after successfull respiratory weaning with symptomatic trachealstenosis

Inclusion criteria

  • Tracheal stenosis after percutaneous tracheotomy.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
250 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Decannulation

    Rate of successful decannulations after intervention up to discharge from inpatient treatment.

    Time frame: 12 months

Secondary outcomes

  1. Technical success

    technical success of the intervention (endoscopically not clinically relevant tracheal stenosis).

    Time frame: 12 months

  2. Reintervention(s)

    Number of interventions required.

    Time frame: 12 months

  3. Type of intervention

    Type of intervention(s) (cyroablation, APC, loop extraction).

    Time frame: 12 months

  4. Clinical success

    Clinical success (no stridor, no dyspnoea).

    Time frame: 12 months

  5. Additional treatment

    Number of patients requiring surgical treatment/stent.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05924087
Lead sponsor
Asklepios Neurological Clinic Bad Salzhausen
Responsible party
Sponsor
First posted
Jun 29, 2023
Start date
Jun 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jul 31, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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