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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon
Groote Schuur Hospital
Cape Town, Western Cape, South Africa
Incidence of peripheral arterial desaturation
Incidence of desaturation below 90% as measured by peripheral pulse oximeter
Time frame: During procedure (up to 60 minutes duration)
Time to desaturation
Time to desaturation below 90% as measured by peripheral pulse oximeter
Time frame: During procedure (up to 60 minutes duration)
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.
Time frame: During procedure (up to 60 minutes duration)
Incidence of major adverse events
Time frame: During and within 24 hours of procedure
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