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NCT03690284

VivaSight Double Lumen Tube for Single Lung Ventilation

Completed NA Results posted Last updated 14 January 2022
What this trial tests

NA trial testing Conventional Double Lumen Tube in Double Lumen Endotracheal Tube in 50 participants. Completed in 31 December 2020.

Timeline
19 June 2019
Primary endpoint
31 December 2020
31 December 2020

Quick facts

Lead sponsorUniversity of Texas Southwestern Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment50
Start date19 June 2019
Primary completion31 December 2020
Estimated completion31 December 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 90, any sex, with Double Lumen Endotracheal Tube or Single Lung Ventilation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Requiring Flexible Fiberoptic Bronchoscopy Primary · Intraoperative, within the time the double lumen was in the trachea

The number of participants requiring flexible fiberoptic bronchoscopy during double-lumen tube intubation for a single lung ventilation.

GroupValue95% CI
Conventional Double Lumen Tube25
VivaSight Double Lumen Tube7
The Intubation Time Secondary · Intraoperative, time to successfully intubate patient.

The time required to place double lumen endotracheal tube for a single lung intubation

GroupValue95% CI
Conventional Double Lumen Tube156103 – 174
VivaSight Double Lumen Tube5445 – 81
Number of Participants With Malposition Secondary · Intraoperative, within the time the double lumen was in the trachea

The number of participants with malposition of double lumen tube for a single lung intubation

GroupValue95% CI
Conventional Double Lumen Tube12
VivaSight Double Lumen Tube4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03690284.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing