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Clinical Trials/NCT05924087
NCT05924087
Recruiting
Not Applicable

Interventional Therapy of Tracheal Stenosis After Percutaneous Tracheotomia

Asklepios Neurological Clinic Bad Salzhausen1 site in 1 country250 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tracheal Stenosis Following Tracheostomy
Sponsor
Asklepios Neurological Clinic Bad Salzhausen
Enrollment
250
Locations
1
Primary Endpoint
Decannulation
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
July 31, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Asklepios Neurological Clinic Bad Salzhausen
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Decannulation

Time Frame: 12 months

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

Secondary Outcomes

  • Additional treatment(12 months)
  • Reintervention(s)(12 months)
  • Clinical success(12 months)
  • Technical success(12 months)
  • Type of intervention(12 months)

Study Sites (1)

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