Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tracheal Stenosis
- Sponsor
- University of Cape Town
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of peripheral arterial desaturation
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
Ross Hofmeyr
Consultant Anaesthesiologist and Clinical Research Fellow in Airway and Thoracic Anaesthesia
University of Cape Town
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
Outcomes
Primary Outcomes
Incidence of peripheral arterial desaturation
Time Frame: During procedure (up to 60 minutes duration)
Incidence of desaturation below 90% as measured by peripheral pulse oximeter
Time to desaturation
Time Frame: During procedure (up to 60 minutes duration)
Time to desaturation below 90% as measured by peripheral pulse oximeter
Secondary Outcomes
- Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading(During procedure (up to 60 minutes duration))
- Incidence of major adverse events(During and within 24 hours of procedure)