The number of participants requiring flexible fiberoptic bronchoscopy during double-lumen tube intubation for a single lung ventilation.
| Group | Value | 95% CI |
|---|---|---|
| Conventional Double Lumen Tube | 25 | |
| VivaSight Double Lumen Tube | 7 |
Last reviewed · How we verify
VivaSight Double Lumen Tube for Single Lung Ventilation
NA trial testing Conventional Double Lumen Tube in Double Lumen Endotracheal Tube in 50 participants. Completed in 31 December 2020.
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 19 June 2019 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across United States |
University of Texas Southwestern Medical Center
Adults 18 to 90, any sex, with Double Lumen Endotracheal Tube or Single Lung Ventilation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of participants requiring flexible fiberoptic bronchoscopy during double-lumen tube intubation for a single lung ventilation.
| Group | Value | 95% CI |
|---|---|---|
| Conventional Double Lumen Tube | 25 | |
| VivaSight Double Lumen Tube | 7 |
The time required to place double lumen endotracheal tube for a single lung intubation
| Group | Value | 95% CI |
|---|---|---|
| Conventional Double Lumen Tube | 156 | 103 – 174 |
| VivaSight Double Lumen Tube | 54 | 45 – 81 |
The number of participants with malposition of double lumen tube for a single lung intubation
| Group | Value | 95% CI |
|---|---|---|
| Conventional Double Lumen Tube | 12 | |
| VivaSight Double Lumen Tube | 4 |
This prospective, randomized, comparative study is intended to enroll a total of 50 patients undergoing thoracic surgery that necessitates single lung ventilation. The efficacy and performance of the VivaSight DLT will be compared to the conventional double lumen tube. Use of fiberoptic bronchoscopy for initial tube positioning and subsequently during the case will be recorded. The attending thoracic surgeon will judge the quality of lung deflation. The occurrence of any malposition and subsequent maneuvers will be recorded. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing