Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures

Study Overview
=================
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.

Official Title
-----------------
Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures

Conditions
-----------------
Tracheal Stenosis

Intervention / Treatment
-----------------
* Device: improved tracheal balloon dilatation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dilatation<br>Patients undergoing tracheal dilatation with the study device | Device: improved tracheal balloon dilatation<br>* Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon<br>* Other names: tracheal balloon dilatation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | During procedure (up to 60 minutes duration) | 
| Incidence of major adverse events |  | During and within 24 hours of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tracheal stenosis, tracheal dilatation, ventilation