VivaSight Double Lumen Tube for Single Lung Ventilation

Not Applicable

Completed

• Conditions: Single Lung Ventilation; Double Lumen Endotracheal Tube
• Interventions: Device: Conventional Double Lumen Tube; Device: VivaSight Double Lumen Tube

• Registration Number: NCT03690284
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2019-06-19
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Results First Submitted: 2021-11-04
• Results First Submitted QC: 2021-11-23
• Results First Posted: 2021-12-23
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Double Lumen Tube	Conventional Double Lumen Tube	Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
VivaSight Double Lumen Tube	VivaSight Double Lumen Tube	Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.

Primary Outcome Measures

Name	Time	Method
Number of Participants Requiring Flexible Fiberoptic Bronchoscopy	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.

Secondary Outcome Measures

Name	Time	Method
The Intubation Time	Intraoperative, time to successfully intubate patient.	The time required to place double lumen endotracheal tube for a single lung intubation
Number of Participants With Malposition	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
The Cost of Double Lumen Tube Intubation	Intraoperative

Trial Locations

Locations (1)

Parkland Health & Hospital System; 🇺🇸 Dallas, Texas, United States