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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Double Lumen Tube | Active Comparator | Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery. |
|
| VivaSight Double Lumen Tube | Experimental | Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Double Lumen Tube | Device | Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Intubation Time | The time required to place double lumen endotracheal tube for a single lung intubation | Intraoperative, time to successfully intubate patient. |
| Number of Participants With Malposition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Moon, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health & Hospital System | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21088594 | Background | 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. | |
| 17211163 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Intraoperative, within the time the double lumen was in the trachea |
|
Monitored for 24 hours after surgery end time.
Adverse events monitored included the following: airway injury, prolonged hypoxia (oxygen saturation <92% for >1 minute), bronchospasm, laryngospasm, aspiration, reintubation, a prolonged postanesthesia care unit (PACU) stay, or unplanned hospital admission.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | University of Texas Southwestern | 3106127741 | matthew.oh@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 18, 2019 | Nov 11, 2021 | Prot_SAP_ICF_000.pdf |
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| 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 |
|
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 |
| The Cost of Double Lumen Tube Intubation | Intraoperative |
| 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. |
| 9477054 | 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. |
| 25663254 | 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. |
| 23439281 | 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. |
| 20601860 | 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. |
| 25179550 | 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. |
| 3344163 | Background | Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available. |
| 21624874 | 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. |
| 11379677 | 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. |
| 28298764 | 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. |
| 26043420 | 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. |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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
|
|
| Secondary | The Intubation Time | The time required to place double lumen endotracheal tube for a single lung intubation | Posted | Median | Inter-Quartile Range | seconds | 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 | Posted | Count of Participants | Participants | Intraoperative, within the time the double lumen was in the trachea |
|
|
|
| Secondary | The Cost of Double Lumen Tube Intubation | This outcome was not measured and no data was collected due to lack of resources to conduct the analysis. | Posted | Intraoperative |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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 | 0 | 25 | 0 | 25 | 0 | 25 |
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