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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilatation | Experimental | Patients undergoing tracheal dilatation with the study device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| improved tracheal balloon dilatation | Device | Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of peripheral arterial desaturation | Incidence of desaturation below 90% as measured by peripheral pulse oximeter | During procedure (up to 60 minutes duration) |
| Time to desaturation | Time to desaturation below 90% as measured by peripheral pulse oximeter | During procedure (up to 60 minutes duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groote Schuur Hospital | Cape Town | Western Cape | 7925 | South Africa |
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| ID | Term |
|---|---|
| D014135 | Tracheal Stenosis |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D014133 | Tracheal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
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| During procedure (up to 60 minutes duration) |
| Incidence of major adverse events | During and within 24 hours of procedure |
| D013568 | Pathological Conditions, Signs and Symptoms |