For A More Comfortable Bronchoscopy: Is Spray Catheter The Answer?

Airway Complication of Anaesthesia Clinical Trial

Official title:

For A More Comfortable Bronchoscopy: Is Spray Catheter The Answer?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02372760
• Other study ID #: UFJ 2014-47
• Status: Withdrawn
• Phase: N/A
• First received: February 3, 2015
• Last updated: December 1, 2015
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Bronchoscopy is a commonly performed procedure for inpatients to visualize the airways when indicated. It is routinely done for both diagnostic (to lavage and biopsy the respiratory tract) and therapeutic purposes (to relief an obstruction or remove foreign bodies). Given the possible side effects of cough of varying severity this procedure can be uncomfortable to patients, some would even shy away from having a bronchoscopy even when it's medically indicated.

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.

Description:

Bronchoscopy is a commonly performed procedure for inpatients. It is routinely done for both diagnostic and therapeutic purposes. The physician in this procedure inserts the bronchoscopy tube that has a camera at its tip to visualize the airways and detect possible pathologies. When needed, he/she can take samples (biopsies), perform brochoalveolar lavage, remove foreign bodies, or relieve airway obstructions.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (18 years of age and above)

• Not mechanically ventilated

• Needing a bronchoscopy as determined by a referring or consulting physician/medical service

Exclusion Criteria:

• Individuals below 18 years of age

• 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Airway Complication of Anaesthesia

Intervention

Device:
• BA by spray catheter (Olympus PW-205V)
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V)

Other:
• BA classic anesthesia
This group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.

Drug:
• Anesthesia
Both groups will receive lidocaine as the anesthesia for bronchoscopy

Locations

Country	Name	City	State
United States	UF Health	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Jakobsen CJ, Ahlburg P, Holdgård 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):1342-50. doi: 10.1378/chest.10-3361. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of coughing episodes during the bronchoscopy	Coughing data will be collected from both groups during the bronchoscopy	Day 1	No
Primary	Severity of cough during the bronchoscopy	Severity of cough data will be collected from both groups during the bronchoscopy	Day 1	No
Primary	Endotracheal sedations required to conduct the bronchoscopy	Endotracheal sedations required to conduct the bronchoscopy between the two groups.	Day 1	No