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OpenTrials
Completed

NCT Number: NCT03690284

VivaSight Double Lumen Tube for Single Lung Ventilation

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.

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Key information

Conditions

Double Lumen Endotracheal Tube Single Lung Ventilation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Conventional Double Lumen Tube

Device

Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery

VivaSight double lumen tube

Device

Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery

Primary outcomes

  1. Number of Participants Requiring Flexible Fiberoptic Bronchoscopy

    Time frame: 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 outcomes

  1. The Intubation Time

    Time frame: Intraoperative, time to successfully intubate patient.

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

  2. Number of Participants With Malposition

    Time frame: 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

  3. The Cost of Double Lumen Tube Intubation

    Time frame: Intraoperative

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

The VivaSight Double Lumen Tube Versus Conventional Double Lumen Tube in Thoracic Surgical Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2018
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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