Tracheal Stenosis
Conditions
Keywords
tracheal stenosis, tracheal dilatation, ventilation
Brief summary
The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.
Detailed description
The primary aim is to determine the incidence of, and time to, arterial desaturation (defined as peripheral plethysmography below 90%). Secondary aims include quantitative and qualitative (waveform) end-tidal capnography levels throughout the procedure, quantitative assessment of dilatation, and incidence of adverse events.
Interventions
DEVICEimproved tracheal balloon dilatation
Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon
Sponsors
University of Cape Town
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Symptoms of tracheal or laryngeal stenosis or airway narrowing * Endoscopic evidence of subglottic or tracheal stenosis * Able to provide informed consent
Exclusion criteria
* Refractory stenosis not amenable to balloon dilatation * Contraindication to balloon dilatation * Lack of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of peripheral arterial desaturation | During procedure (up to 60 minutes duration) | Incidence of desaturation below 90% as measured by peripheral pulse oximeter |
| Time to desaturation | During procedure (up to 60 minutes duration) | Time to desaturation below 90% as measured by peripheral pulse oximeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading | During procedure (up to 60 minutes duration) | Describes the stenosis based on the percent relative reduction in cross-sectional area of the subglottis. Four grades of stenosis: grade I lesions have less than 50% obstruction, grade II lesions have 51% to 70% obstruction, grade III lesions have 71% to 99% obstruction, grade IV lesions have no detectable lumen or complete stenosis. |
| Incidence of major adverse events | During and within 24 hours of procedure | — |
Countries
South Africa
Outcome results
None listed