Idiopathic progressive subglottic stenosis J38.6
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis: Idiopathic progressive subglottic stenosis (IPSS) - Ability to consent: Patients must be capable of providing informed consent independently and voluntarily. - Balloon dilation prescribed independently of the study: Only patients in whom balloon dilation was prescribed as a therapeutic measure independently of the study will be included.
Exclusion criteria
Exclusion criteria: - Previous surgeries such as cricotracheal resection (CTR), laryngotracheal reconstruction (LTR) - Long-term intubation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Retrospective study: - Frequency of balloon dilations over the past 10 years. - Progression of stenosis severity (based on ELS classification) between procedures. - Occurrence of complications related to balloon dilation. b. Prospective study: - Significant improvement in breathing as measured by the 6-minute walk test (difference in distance walked pre- and postoperatively) and by peak expiratory flow (PEF) values. - No significant changes in voice function (assessed by voice range profile and the Voice Handicap Index [VHI-9]). - No changes in swallowing function, based on the MD Anderson Dysphagia Inventory (MDADI) and the swallowing test (Dysphagia Severity Scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Influence of patient demographics (age, initial diagnosis) and previous surgeries on treatment outcome. - Evaluation of subjective treatment success (patient satisfaction). | — |
Countries
Germany
Contacts
Klinikum Stuttgart