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

Not Applicable

Completed

• Conditions: Tracheal Stenosis
• Interventions: Device: improved tracheal balloon dilatation

• Registration Number: NCT02796326
• Lead Sponsor: University of Cape Town

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.

Study Timeline

• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Study Start: 2016-10
• Primary Completion: 2017-06-30
• Study Completion: 2017-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dilatation	improved tracheal balloon dilatation	Patients undergoing tracheal dilatation with the study device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Groote Schuur Hospital; 🇿🇦 Cape Town, Western Cape, South Africa