VivaSight Double Lumen Tube for Single Lung Ventilation

NCT03690284 | Completed Results DMC FDA Device

• 1 other identifier: STU-2018-0098
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Double Lumen Endotracheal Tube; Single Lung Ventilation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Requiring Flexible Fiberoptic Bronchoscopy

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

  Intraoperative, within the time the double lumen was in the trachea

Secondary Outcomes (3)

• The Intubation Time

  Intraoperative, time to successfully intubate patient.

• Number of Participants With Malposition

  Intraoperative, within the time the double lumen was in the trachea

• The Cost of Double Lumen Tube Intubation

  Intraoperative

Study Arms (2)

Conventional Double Lumen Tube

ACTIVE COMPARATOR

Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.

Device: Conventional Double Lumen Tube

VivaSight Double Lumen Tube

EXPERIMENTAL

Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.

Device: VivaSight Double Lumen Tube

Interventions

Conventional Double Lumen Tube DEVICE

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

Conventional Double Lumen Tube

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

VivaSight Double Lumen Tube

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Scheduled for a thoracic surgery that requires single lung ventilation
• Willing and able to consent in English or Spanish

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

Related Publications (12)

• Campos JH, Hallam EA, Ueda K. Training in placement of the left-sided double-lumen tube among non-thoracic anaesthesiologists: intubation model simulator versus computer-based digital video disc, a randomised controlled trial. Eur J Anaesthesiol. 2011 Mar;28(3):169-74. doi: 10.1097/EJA.0b013e328340c332.

  PMID: 21088594 BACKGROUND

• Campos JH. Which device should be considered the best for lung isolation: double-lumen endotracheal tube versus bronchial blockers. Curr Opin Anaesthesiol. 2007 Feb;20(1):27-31. doi: 10.1097/ACO.0b013e3280111e2a.

  PMID: 17211163 BACKGROUND

• Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.

  PMID: 9477054 BACKGROUND

• Schuepbach R, Grande B, Camen G, Schmidt AR, Fischer H, Sessler DI, Seifert B, Spahn DR, Ruetzler K. Intubation with VivaSight or conventional left-sided double-lumen tubes: a randomized trial. Can J Anaesth. 2015 Jul;62(7):762-9. doi: 10.1007/s12630-015-0329-8. Epub 2015 Feb 6.

  PMID: 25663254 BACKGROUND

• Porhomayon J, Papadakos P, Singh A, Nader ND. Alteration in respiratory physiology in obesity for anesthesia-critical care physician. HSR Proc Intensive Care Cardiovasc Anesth. 2011;3(2):109-18.

  PMID: 23439281 BACKGROUND

• Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.

  PMID: 20601860 BACKGROUND

• Amorim P, Lagarto F, Gomes B, Esteves S, Bismarck J, Rodrigues N, Nogueira M. Neostigmine vs. sugammadex: observational cohort study comparing the quality of recovery using the Postoperative Quality Recovery Scale. Acta Anaesthesiol Scand. 2014 Oct;58(9):1101-10. doi: 10.1111/aas.12389. Epub 2014 Sep 1.

  PMID: 25179550 BACKGROUND

• Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.

  PMID: 3344163 BACKGROUND

• Baxter AL, Watcha MF, Baxter WV, Leong T, Wyatt MM. Development and validation of a pictorial nausea rating scale for children. Pediatrics. 2011 Jun;127(6):e1542-9. doi: 10.1542/peds.2010-1410. Epub 2011 May 29.

  PMID: 21624874 BACKGROUND

• Doufas AG, Bakhshandeh M, Bjorksten AR, Greif R, Sessler DI. Automated responsiveness test (ART) predicts loss of consciousness and adverse physiologic responses during propofol conscious sedation. Anesthesiology. 2001 Apr;94(4):585-92. doi: 10.1097/00000542-200104000-00010.

  PMID: 11379677 BACKGROUND

• Chattopadhyay S, Das A, Nandy S, RoyBasunia S, Mitra T, Halder PS, Chhaule S, Mandal SK. Postoperative Sore Throat Prevention in Ambulatory Surgery: A Comparison between Preoperative Aspirin and Magnesium Sulfate Gargle - A Prospective, Randomized, Double-blind Study. Anesth Essays Res. 2017 Jan-Mar;11(1):94-100. doi: 10.4103/0259-1162.186602.

  PMID: 28298764 BACKGROUND

• Reiter R, Hoffmann TK, Pickhard A, Brosch S. Hoarseness-causes and treatments. Dtsch Arztebl Int. 2015 May 8;112(19):329-37. doi: 10.3238/arztebl.2015.0329.

  PMID: 26043420 BACKGROUND

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: University of Texas Southwestern

matthew.oh@utsouthwestern.edu

3106127741

Study Officials

• Tiffany Moon, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 1, 2018
• Study Start: June 19, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 14, 2022
• Results First Posted: December 23, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)