Interventional Therapy of Tracheal Stenosis

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheal Stenosis Following Tracheostomy

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Germany
  • Nidda, Germany, 63667
    • Recruiting
    • Neurologische Klinik Bad Salzhausen
    • Contact: Dirk Bandorski, MD, PhD; Phone Number: +496043804212; Email: d.bandorski@asklepios.com
    • Contact: Pascal Klingenberger, MD; Email: p.klingenberger@asklepios.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients after successfull respiratory weaning with symptomatic trachealstenosis

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decannulation	Rate of successful decannulations after intervention up to discharge from inpatient treatment.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	technical success of the intervention (endoscopically not clinically relevant tracheal stenosis).	12 months
Reintervention(s)	Number of interventions required.	12 months
Type of intervention	Type of intervention(s) (cyroablation, APC, loop extraction).	12 months
Clinical success	Clinical success (no stridor, no dyspnoea).	12 months
Additional treatment	Number of patients requiring surgical treatment/stent.	12 months

Collaborators and Investigators

• Sponsor: Asklepios Neurological Clinic Bad Salzhausen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 10, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pathological Conditions, Anatomical; Tracheal Diseases; Constriction, Pathologic; Tracheal Stenosis
• Other Study ID Numbers: ITTS10_06_2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No