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Interventional Therapy of Tracheal Stenosis

Interventional Therapy of Tracheal Stenosis After Percutaneous Tracheotomia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05924087
Enrollment
250
Registered
2023-06-29
Start date
2023-06-01
Completion date
2026-07-31
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal Stenosis Following Tracheostomy

Brief 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.

Interventions

None listed

Sponsors

Asklepios Neurological Clinic Bad Salzhausen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Tracheal stenosis after percutaneous tracheotomy.

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).

Design outcomes

Primary

MeasureTime frameDescription
Decannulation12 monthsRate of successful decannulations after intervention up to discharge from inpatient treatment.

Secondary

MeasureTime frameDescription
Technical success12 monthstechnical success of the intervention (endoscopically not clinically relevant tracheal stenosis).
Reintervention(s)12 monthsNumber of interventions required.
Type of intervention12 monthsType of intervention(s) (cyroablation, APC, loop extraction).
Clinical success12 monthsClinical success (no stridor, no dyspnoea).
Additional treatment12 monthsNumber of patients requiring surgical treatment/stent.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026