VivaSight Double Lumen Tube for Single Lung Ventilation

Single Lung Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690284
• Other study ID #: STU-2018-0098
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Double Lumen Endotracheal Tube
• Single Lung Ventilation

Intervention

Device:
• Conventional Double Lumen Tube
Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
• VivaSight Double Lumen Tube
Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery

Locations

Country	Name	City	State
United States	Parkland Health & Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. Erratum in: Pediatrics. 2011 Nov;128(5):1004. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Intubation Time	The time required to place double lumen endotracheal tube for a single lung intubation	Intraoperative, time to successfully intubate patient.
Secondary	Number of Participants With Malposition	The number of participants with malposition of double lumen tube for a single lung intubation	Intraoperative, within the time the double lumen was in the trachea
Secondary	The Cost of Double Lumen Tube Intubation		Intraoperative