Back to resultsModified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
Primary Purpose
Tracheal Stenosis
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
improved tracheal balloon dilatation
Sponsored by
About this trial
This is an interventional treatment trial for Tracheal Stenosis focused on measuring tracheal stenosis, tracheal dilatation, ventilation
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
Sites / Locations
- Groote Schuur Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dilatation
Arm Description
Patients undergoing tracheal dilatation with the study device
Outcomes
Primary Outcome Measures
Incidence of peripheral arterial desaturation
Incidence of desaturation below 90% as measured by peripheral pulse oximeter
Time to desaturation
Time to desaturation below 90% as measured by peripheral pulse oximeter
Secondary Outcome Measures
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.
Incidence of major adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02796326
Brief Title
Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
Official Title
Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheal Stenosis
Keywords
tracheal stenosis, tracheal dilatation, ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dilatation
Arm Type
Experimental
Arm Description
Patients undergoing tracheal dilatation with the study device
Intervention Type
Device
Intervention Name(s)
improved tracheal balloon dilatation
Other Intervention Name(s)
tracheal balloon dilatation
Intervention Description
Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon
Primary Outcome Measure Information:
Title
Incidence of peripheral arterial desaturation
Description
Incidence of desaturation below 90% as measured by peripheral pulse oximeter
Time Frame
During procedure (up to 60 minutes duration)
Title
Time to desaturation
Description
Time to desaturation below 90% as measured by peripheral pulse oximeter
Time Frame
During procedure (up to 60 minutes duration)
Secondary Outcome Measure Information:
Title
Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading
Description
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)
Title
Incidence of major adverse events
Time Frame
During and within 24 hours of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Groote Schuur Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
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