VivaSight Double Lumen Tube for Single Lung Ventilation
NCT ID: NCT03690284
Last Updated: 2022-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-06-19
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Conventional Double Lumen Tube
Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
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 VivaSight 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Scheduled for a thoracic surgery that requires single lung ventilation
* Willing and able to consent in English or Spanish
Exclusion Criteria
* 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)
18 Years
90 Years
ALL
Yes
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Tiffany B Moon
Associate Professor
Principal Investigators
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Tiffany Moon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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Parkland Health & Hospital System
Dallas, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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STU-2018-0098
Identifier Type: -
Identifier Source: org_study_id
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