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

Tracheal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796326
• Other study ID #: UCTAnaes-2016-01
• Status: Completed
• Phase: N/A
• First received: June 1, 2016
• Last updated: October 27, 2017
• Start date: October 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2017
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tracheal Stenosis

Intervention

Device:
• improved tracheal balloon dilatation
Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of peripheral arterial desaturation	Incidence of desaturation below 90% as measured by peripheral pulse oximeter	During procedure (up to 60 minutes duration)
Primary	Time to desaturation	Time to desaturation below 90% as measured by peripheral pulse oximeter	During procedure (up to 60 minutes duration)
Secondary	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)
Secondary	Incidence of major adverse events		During and within 24 hours of procedure