For A More Comfortable Bronchoscopy: Is Spray Catheter The Answer?
NCT ID: NCT02372760
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-02-28
2015-12-31
Brief Summary
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Recently a spray catheter was designed to deliver more uniform anesthesia to the airways as compared to the conventional way of injecting the anesthesia into the bronchoscopy working channel. The investigators aim to conduct this study with the hope of improving patient care, providing comfortable procedures, helping more patients opt in for bronchoscopy when indicated.
Detailed Description
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The usual method of Bronchoscopic Anesthesia (BA) is conscious sedation combined with local anesthesia as it's more comfortable for the patients, with less chances of lidocaine toxicity. Local anesthesia is classically done using lidocaine injected through the bronchoscope's working channel. As the operator starts from the upper airway, they anesthetize each part as they go down to examine the lungs. The lidocaine will be delivered to the airway as it drips out of the working channel into the airway part closest to it. Side effects of this method is cough with varying frequencies/severity that may sometimes hinder the procedure.
Recently, a spray catheter was designed and used, but mainly for EBUS (Endobronchial Ultrasound) and not for bronchoscopy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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BA by spray catheter (Olympus PW-205V)
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V).
BA by spray catheter (Olympus PW-205V)
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V)
Anesthesia
Both groups will receive lidocaine as the anesthesia for bronchoscopy
BA classic anesthesia
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
BA classic anesthesia
This group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
Anesthesia
Both groups will receive lidocaine as the anesthesia for bronchoscopy
Interventions
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BA by spray catheter (Olympus PW-205V)
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V)
BA classic anesthesia
This group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
Anesthesia
Both groups will receive lidocaine as the anesthesia for bronchoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not mechanically ventilated
* Needing a bronchoscopy as determined by a referring or consulting physician/medical service
Exclusion Criteria
* Pregnant women
* Terminally-ill patients
* Patients who are unable to consent in person
* Patients with contraindications for bronchoscopy (according to British Thoracic Society 2013 Guidelines this includes patients with acute myocardial infarction and patients in acute respiratory distress)
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Adil Shujaat, MD
Role: PRINCIPAL_INVESTIGATOR
University at Buffalo
Locations
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UF Health
Jacksonville, Florida, United States
Countries
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References
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Stolz D, Chhajed PN, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: a randomized, double-blind, placebo-controlled trial. Chest. 2005 Sep;128(3):1756-60. doi: 10.1378/chest.128.3.1756.
De S. Assessment of patient satisfaction and lidocaine requirement during flexible bronchoscopy without sedation. J Bronchology Interv Pulmonol. 2009 Jul;16(3):176-9. doi: 10.1097/LBR.0b013e3181afca25.
Jakobsen CJ, Ahlburg P, Holdgard HO, Olsen KH, Thomsen A. Comparison of intravenous and topical lidocaine as a suppressant of coughing after bronchoscopy during general anesthesia. Acta Anaesthesiol Scand. 1991 Apr;35(3):238-41. doi: 10.1111/j.1399-6576.1991.tb03280.x.
Antoniades N, Worsnop C. Topical lidocaine through the bronchoscope reduces cough rate during bronchoscopy. Respirology. 2009 Aug;14(6):873-6. doi: 10.1111/j.1440-1843.2009.01587.x.
Lee HJ, Haas AR, Sterman DH, Solly R, Vachani A, Gillespie CT. Pilot randomized study comparing two techniques of airway anaesthesia during curvilinear probe endobronchial ultrasound bronchoscopy (CP-EBUS). Respirology. 2011 Jan;16(1):102-6. doi: 10.1111/j.1440-1843.2010.01861.x.
Kenzaki K, Hirose Y, Tamaki M, Sakiyama S, Kondo K, Mutsuda T, Monden Y. Novel bronchofiberscopic catheter spray device allows effective anesthetic spray and sputum suctioning. Respir Med. 2004 Jul;98(7):606-10. doi: 10.1016/j.rmed.2004.01.002.
Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.
Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.
Other Identifiers
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UFJ 2014-47
Identifier Type: -
Identifier Source: org_study_id