NCT05924087

Interventional Therapy of Tracheal Stenosis

Recruiting now Last updated 31 July 2024

What this trial tests

trial in Tracheal Stenosis Following Tracheostomy in 250 participants. Currently enrolling.

Timeline

1 June 2023

Primary endpoint
31 December 2025

31 July 2026

Quick facts

Lead sponsor	Asklepios Neurological Clinic Bad Salzhausen
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	250
Start date	1 June 2023
Primary completion	31 December 2025
Estimated completion	31 July 2026
Sites	1 location across Germany

Conditions studied

• Tracheal Stenosis Following Tracheostomy — all drugs for Tracheal Stenosis Following Tracheostomy →

Sponsor

Asklepios Neurological Clinic Bad Salzhausen

Who can join

18 and older, any sex, with Tracheal Stenosis Following Tracheostomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventional treatment of post tracheostomy tracheal stenosis in neurological rehabilitation: results of a single-center registry.
   Ley L, Klingenberger P, Schlitter T, Hetzel J, et al · · 2026 · PMID 41908175 · DOI 10.3389/fresc.2026.1776925