Washing Pipe with a Spray Nozzle for Topical Anesthesia During Bronchoscopy

NCT05970848 | Completed

• 1 other identifier: 202302060RINC
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized control trial is to evaluate the effectiveness and safety of using a spray nozzle, compared to the conventional method, for topical anesthesia by the spray-as-you-go technique in reducing cough frequency, improving cough, discomfort, tolerance, satisfaction, reducing the dosage of lidocaine consumption of patients during flexible bronchoscopy.

Conditions

Pulmonary Disease

Keywords

flexible bronchoscopy; topical airway anesthesia

Outcome Measures

Primary Outcomes (1)

• Cough rate

  The bronchoscopy procedure will be audio-taped throughout and cough counting will be recorded by an investigator blinded to the patient information and grouping. The cough rate will be calculated as total cough counts divided by procedure time in minute.

  Through the duration of the bronchoscopy exam, an average of 30 min

Secondary Outcomes (5)

• Procedure time

  Through the duration of the bronchoscopy exam, an average of 30 min

• Lidocaine dosage

  Through the duration of the bronchoscopy exam, an average of 30 min

• Patient tolerance

  Through the duration of the bronchoscopy exam, an average of 30 min

• Patient satisfaction

  Through the duration of the bronchoscopy exam, an average of 30 min

• Adverse events

  Through the duration of the bronchoscopy exam, an average of 30 min

Study Arms (2)

Group S

EXPERIMENTAL

Group S patients will receive topical lidocaine anesthesia via the spray nozzle by the spray as-you-go technique during flexible bronchoscopy.

Device: Washing Pipe With a Spray Nozzle

Group C

NO INTERVENTION

Group C patients will receive topical lidocaine anesthesia with the conventional method by the spray as-you-go technique during flexible bronchoscopy.

Interventions

Washing Pipe With a Spray Nozzle DEVICE

Administration of topical airway anesthesia via a washing pipe with a spray nozzle using the spray-as-you-go technique

Group S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• A planned flexible bronchoscopy
• Being able to communicate with Mandarin Chinese or Taiwanese Hokkien

You may not qualify if:

• are unwilling to join the study
• have tracheostomy or are intubated
• will receive intravenous anesthesia during flexible bronchoscopy
• known to be pregnant

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (14)

• 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.

  PMID: 23860341 BACKGROUND

• Criner GJ, Eberhardt R, Fernandez-Bussy S, Gompelmann D, Maldonado F, Patel N, Shah PL, Slebos DJ, Valipour A, Wahidi MM, Weir M, Herth FJ. Interventional Bronchoscopy. Am J Respir Crit Care Med. 2020 Jul 1;202(1):29-50. doi: 10.1164/rccm.201907-1292SO.

  PMID: 32023078 BACKGROUND

• Mohan A, Madan K, Hadda V, Tiwari P, Mittal S, Guleria R, Khilnani GC, Luhadia SK, Solanki RN, Gupta KB, Swarnakar R, Gaur SN, Singhal P, Ayub II, Bansal S, Bista PR, Biswal SK, Dhungana A, Doddamani S, Dubey D, Garg A, Hussain T, Iyer H, Kavitha V, Kalai U, Kumar R, Mehta S, Nongpiur VN, Loganathan N, Sryma PB, Pangeni RP, Shrestha P, Singh J, Suri T, Agarwal S, Agarwal R, Aggarwal AN, Agrawal G, Arora SS, Thangakunam B, Behera D; Jayachandra; Chaudhry D, Chawla R, Chawla R, Chhajed P, Christopher DJ, Daga MK, Das RK, D'Souza G, Dhar R, Dhooria S, Ghoshal AG, Goel M, Gopal B, Goyal R, Gupta N, Jain NK, Jain N, Jindal A, Jindal SK, Kant S, Katiyar S, Katiyar SK, Koul PA, Kumar J, Kumar R, Lall A, Mehta R, Nath A, Pattabhiraman VR, Patel D, Prasad R, Samaria JK, Sehgal IS, Shah S, Sindhwani G, Singh S, Singh V, Singla R, Suri JC, Talwar D, Jayalakshmi TK, Rajagopal TP. Guidelines for diagnostic flexible bronchoscopy in adults: Joint Indian Chest Society/National College of chest physicians (I)/Indian association for bronchology recommendations. Lung India. 2019 Jul;36(Supplement):S37-S89. doi: 10.4103/lungindia.lungindia_108_19.

  PMID: 32445309 BACKGROUND

• Madan K, Mohan A, Agarwal R, Hadda V, Khilnani GC, Guleria R. A survey of flexible bronchoscopy practices in India: The Indian bronchoscopy survey (2017). Lung India. 2018 Mar-Apr;35(2):98-107. doi: 10.4103/lungindia.lungindia_417_17.

  PMID: 29487243 BACKGROUND

• 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.

  PMID: 22045879 BACKGROUND

• Kim SY, Lee HJ, Lee JK, Park TY, Heo EY, Kim DK, Chung HS, Lee HW. Association between oxygen saturation level during bronchoscopy and post-bronchoscopy adverse events: a retrospective cohort study. Respir Res. 2022 Jun 2;23(1):144. doi: 10.1186/s12931-022-02063-0.

  PMID: 35655299 BACKGROUND

• Fujimoto K, Ishiwata T, Kasai H, Terada J, Shionoya Y, Ikari J, Kawata N, Tada Y, Tsushima K, Tatsumi K. Identification of factors during bronchoscopy that affect patient reluctance to undergo repeat examination: Questionnaire analysis after initial bronchoscopy. PLoS One. 2018 Dec 6;13(12):e0208495. doi: 10.1371/journal.pone.0208495. eCollection 2018.

  PMID: 30521615 BACKGROUND

• Ling IT, Piccolo F, Mulrennan SA, Phillips MJ. Posture influences patient cough rate, sedative requirement and comfort during bronchoscopy: An observational cohort study. Cough. 2011 Nov 10;7:9. doi: 10.1186/1745-9974-7-9.

  PMID: 22074355 BACKGROUND

• 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.

  PMID: 19703068 BACKGROUND

• Cai Y, Chen L, Dong D, Ye M, Jin X, Liu F. The utility of a multi-orifice epidural catheter when using the "Spray-as-You-Go" technique for topical Airway Anesthesia during Flexible Bronchoscopy, a randomised trial. J Clin Monit Comput. 2023 Feb;37(1):55-62. doi: 10.1007/s10877-022-00856-8. Epub 2022 Apr 20.

  PMID: 35441943 BACKGROUND

• Venkatnarayan K, Devaraj U, Krishnaswamy UM, Ramachandran P, Thomas T, D'Souza G. Comparison of spray catheter with "spray-as-you-go" technique for airway anesthesia during flexible bronchoscopy - A randomized trial. Lung India. 2020 Sep-Oct;37(5):384-388. doi: 10.4103/lungindia.lungindia_528_19.

  PMID: 32883896 BACKGROUND

• Yildirim F, Ozkaya S, Yurdakul AS. Factors affecting patients' comfort during fiberoptic bronchoscopy and endobronchial ultrasound. J Pain Res. 2017 Mar 29;10:775-781. doi: 10.2147/JPR.S118047. eCollection 2017.

  PMID: 28435314 BACKGROUND

• Kobayashi F, Saraya T, Oda M, Sakuma S, Watanabe M, Takata S, Tamura M, Takakura H, Nakamoto K, Honda K, Ohkuma K, Mikura S, Inoue M, Hirata A, Kurokawa N, Shirai T, Aso K, Noda A, Miyaoka C, Yoshida Y, Ishikawa N, Morita K, Ieki E, Nakajima H, Ishii H, Takizawa H. Novel predictive factors for patient discomfort and severe cough during bronchoscopy: A prospective questionnaire analysis. PLoS One. 2020 Oct 19;15(10):e0240485. doi: 10.1371/journal.pone.0240485. eCollection 2020.

  PMID: 33075060 BACKGROUND

• Lechtzin N, Rubin HR, White P Jr, Jenckes M, Diette GB. Patient satisfaction with bronchoscopy. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1326-31. doi: 10.1164/rccm.200203-231OC. Epub 2002 Jul 19.

  PMID: 12406852 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Chao-Chi Ho, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly allocated into one of the two groups by the randomization module in REDCap. Patients and outcomes assessor will be blinded to their grouping.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Group S patients will receive topical lidocaine anesthesia via the spray nozzle by the spray as-you-go technique during flexible bronchoscopy. Group C patients will receive topical lidocaine anesthesia with the conventional method by the spray as-you-go technique during flexible bronchoscopy.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: August 1, 2023
• Study Start: May 31, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)