Washing Pipe with a Spray Nozzle for Topical Anesthesia During Bronchoscopy

NCT ID: NCT05970848

Last Updated: 2024-10-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Group S

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

Group Type EXPERIMENTAL

Washing Pipe With a Spray Nozzle

Intervention Type DEVICE

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

Group C

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Washing Pipe With a Spray Nozzle

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older
2. A planned flexible bronchoscopy
3. Being able to communicate with Mandarin Chinese or Taiwanese Hokkien

Exclusion Criteria

1. are unwilling to join the study
2. have tracheostomy or are intubated
3. will receive intravenous anesthesia during flexible bronchoscopy
4. known to be pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Statistical Center, NTUHCTC

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chao-Chi Ho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 23860341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32023078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32445309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29487243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22045879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35655299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30521615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22074355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19703068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35441943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32883896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28435314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33075060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12406852 (View on PubMed)

Other Identifiers

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202302060RINC

Identifier Type: -

Identifier Source: org_study_id

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