An observational study in Tracheal Stenosis Following Tracheostomy, sponsored by Asklepios Neurological Clinic Bad Salzhausen. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Asklepios Neurological Clinic Bad Salzhausen · Observational
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.
37 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.
This study's planned enrollment of 250 is above the median of 78 across 12 observational studies indexed under Tracheal Stenosis.
Browse Tracheal Stenosis studies →Asklepios Neurological Clinic Bad Salzhausen is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients after successfull respiratory weaning with symptomatic trachealstenosis
Exclusion Criteria:
Decannulation
Rate of successful decannulations after intervention up to discharge from inpatient treatment.
Time frame: 12 months
Technical success
technical success of the intervention (endoscopically not clinically relevant tracheal stenosis).
Time frame: 12 months
Reintervention(s)
Number of interventions required.
Time frame: 12 months
Type of intervention
Type of intervention(s) (cyroablation, APC, loop extraction).
Time frame: 12 months
Clinical success
Clinical success (no stridor, no dyspnoea).
Time frame: 12 months
Additional treatment
Number of patients requiring surgical treatment/stent.
Time frame: 12 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Asklepios Neurological Clinic Bad Salzhausen