Interventional Therapy of Tracheal Stenosis

NCT05924087 | Recruiting

• 1 other identifier: ITTS10_06_2023
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheal Stenosis Following Tracheostomy

Outcome Measures

Primary Outcomes (1)

• Decannulation

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

  12 months

Secondary Outcomes (5)

• Technical success

  12 months

• Reintervention(s)

  12 months

• Type of intervention

  12 months

• Clinical success

  12 months

• Additional treatment

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients after successfull respiratory weaning with symptomatic trachealstenosis

You may qualify if:

• Tracheal stenosis after percutaneous tracheotomy.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Asklepios Neurological Clinic Bad Salzhausen: lead

Study Sites (1)

Neurologische Klinik Bad Salzhausen

Nidda, 63667, Germany

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: June 29, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

DE (1)