Operative, Non Cardiac, Thoracic Disease Clinical Trial
Official title:
A Comparison of Intraluminal and Extraluminal Placement of the Arndt Bronchial Blockers for Adult Thoracic Surgery
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the time and ease of placement of an extra-luminal
Arndt bronchial blocker versus placing it intra-luminally.
An additional objective will be to assess if there are any other significant clinical
differences between these two approaches to placement of the BB including overall quality of
isolation, an increase in post-operatives sore throat, post-operative hoarseness, and
increased incidence of needing to reposition the blocker
Status | Completed |
Enrollment | 42 |
Est. completion date | September 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age greater than 18 and <80 - Patients scheduled for non cardiac, thoracic surgery requiring lung isolation Exclusion Criteria: - History of difficult airway/intubation - Patients suspected to have a difficult airway - Morbid obesity BMI >39 - Pregnancy - Emergency status of surgery |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
Bastien JL, O'Brien JG, Frantz FW. Extraluminal use of the Arndt pediatric endobronchial blocker in an infant: a case report. Can J Anaesth. 2006 Feb;53(2):159-61. — View Citation
Campos JH, Hallam EA, Van Natta T, Kernstine KH. Devices for lung isolation used by anesthesiologists with limited thoracic experience: comparison of double-lumen endotracheal tube, Univent torque control blocker, and Arndt wire-guided endobronchial blocker. Anesthesiology. 2006 Feb;104(2):261-6, discussion 5A. — View Citation
Clayton-Smith A, Bennett K, Alston RP, Adams G, Brown G, Hawthorne T, Hu M, Sinclair A, Tan J. A Comparison of the Efficacy and Adverse Effects of Double-Lumen Endobronchial Tubes and Bronchial Blockers in Thoracic Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):955-66. doi: 10.1053/j.jvca.2014.11.017. Epub 2014 Dec 2. Review. — View Citation
Hsieh VC, Thompson DR, Haberkern CM. Pediatric endobronchial blockers in infants: a refinement in technique. Paediatr Anaesth. 2015 Apr;25(4):438-9. doi: 10.1111/pan.12568. — View Citation
Knoll H, Ziegeler S, Schreiber JU, Buchinger H, Bialas P, Semyonov K, Graeter T, Mencke T. Airway injuries after one-lung ventilation: a comparison between double-lumen tube and endobronchial blocker: a randomized, prospective, controlled trial. Anesthesiology. 2006 Sep;105(3):471-7. — View Citation
Stephenson LL, Seefelder C. Routine extraluminal use of the 5F Arndt Endobronchial Blocker for one-lung ventilation in children up to 24 months of age. J Cardiothorac Vasc Anesth. 2011 Aug;25(4):683-6. doi: 10.1053/j.jvca.2010.04.020. Epub 2010 Jul 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of Lung Isolation | The investigators will use a qualitative scale. 1-Perfect lung isolation and operative conditions. 2-Acceptable lung isolation and operative conditions, 3-No lung isolation and poor operative conditions. The surgeon will be queried every 30 minutes. The means for the two groups will be compared for statistical significance. | Duration of surgery | |
Primary | Time for placement of an extra-luminal Arndt bronchial blocker versus placing it intra-luminally | <8 minutes | ||
Secondary | Sore Throat | The investigator will query the study participants on post op days 1 and 2, and will use a qualitative scale from 1-4. 1-No Sore throat, 2-mild sorethroat, 3-moderate sorethroat, 4-severe sorethroat. The investigators will the compare means from the arms of the study. | <48hrs postop |