Trials / Completed
CompletedNCT02796326
Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Cape Town · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | improved tracheal balloon dilatation | Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2017-06-30
- Completion
- 2017-09-30
- First posted
- 2016-06-10
- Last updated
- 2017-10-30
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT02796326. Inclusion in this directory is not an endorsement.