N/A
N=50
VivaSight Double Lumen Tube for Single Lung Ventilation
Double Lumen Endotracheal Tube · Single Lung Ventilation
Bottom Line
View on ClinicalTrials.gov: NCT03690284 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Number of Participants Requiring Flexible Fiberoptic Bronchoscopy — 25; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Conventional Double Lumen Tube (Device); VivaSight Double Lumen Tube (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Requiring Flexible Fiberoptic Bronchoscopy |
25; 7 | — |
| SECONDARY The Intubation Time |
156; 54 | — |
| SECONDARY Number of Participants With Malposition |
12; 4 | — |
| SECONDARY The Cost of Double Lumen Tube Intubation |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 18-90 years old
- Scheduled for a thoracic surgery that requires single lung ventilation
- Willing and able to consent in English or Spanish
Exclusion Criteria
- Age less than 18 or older than 90
- Patient does not speak English or Spanish
- Patient refusal
- Pregnant or nursing women
- Known or suspected difficult airway
- Contraindication for left sided double lumen tube (e.g, L bronchial mass)
Data sourced from ClinicalTrials.gov (NCT03690284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.