Pulmonary DiseaseNCT05970848

Washing Pipe with a Spray Nozzle for Topical Anesthesia During Bronchoscopy

A study testing Washing Pipe With a Spray Nozzle in people with Pulmonary Disease, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Disease
What is being tested?: Washing Pipe With a Spray Nozzle
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteTaiwan
Study dates: 31 May 2023to 31 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taiwan University Hospital
Taipei

Other trials in Taiwan

About this study

Official title: Washing Pipe with a Spray Nozzle for Topical Airway Anesthesia Using the Spray-as-You-Go Technique During Flexible Bronchoscopy: a Randomized Control Trial

Conditions: Pulmonary Disease
Being tested: Washing Pipe With a Spray Nozzle
Keywords: flexible bronchoscopy, topical airway anesthesia
Medical subject headings: Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Washing Pipe With a Spray NozzleDevice
Administration of topical airway anesthesia via a washing pipe with a spray nozzle using the spray-as-you-go technique

Study groups in NCT05970848
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Through the duration of the bronchoscopy exam, an average of 30 min

Secondary outcomes (5)

Procedure time
The duration (minute) of the bronchoscopic procedure
Measured: Through the duration of the bronchoscopy exam, an average of 30 min
Lidocaine dosage
Total lidocaine doses dispensed during the bronchoscopic procedure
Measured: Through the duration of the bronchoscopy exam, an average of 30 min
Patient tolerance
Using a visual analogue scale from 0 to 10 to indicate patient tolerance of the bronchoscopy
Measured: Through the duration of the bronchoscopy exam, an average of 30 min
Patient satisfaction
Using a visual analogue scale from 0 to 10 to indicate patient satisfaction of the bronchoscopy
Measured: Through the duration of the bronchoscopy exam, an average of 30 min
Adverse events
Development of adverse events during the bronchoscopic procedure, such as bleeding and oxygen desaturation
Measured: Through the duration of the bronchoscopy exam, an average of 30 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 202331 Aug 2023

First posted1 Aug 2023
Study start31 May 2023
Primary completion31 Aug 2023
Study completion31 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05970848
Sponsor's protocol ID: 202302060RINC
Status last verified: Oct 2024
First submitted: 24 May 2023
Last updated: 21 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23860341
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.
PubMed 32023078
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.
PubMed 32445309
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.
PubMed 29487243
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.
PubMed 22045879
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.
PubMed 35655299
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.
PubMed 30521615
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.
PubMed 22074355
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.
PubMed 19703068
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.
PubMed 35441943
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.
PubMed 32883896
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.
PubMed 28435314
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.
PubMed 33075060
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.
PubMed 12406852

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Washing Pipe with a Spray Nozzle for Topical Airway Anesthesia Using the Spray-as-You-Go Technique During Flexible Bronchoscopy: a Randomized Control Trial
ClinicalTrials.gov ID: NCT05970848
Acronym / sponsor ID: 202302060RINC
Conditions: Pulmonary Disease
Keywords: flexible bronchoscopy, topical airway anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: National Taiwan University HospitalUniversity, hospital or other
Study start: 31 May 2023 (actual)
Primary completion: 31 Aug 2023 (actual)
Study completion: 31 Aug 2023 (actual)
First posted: 1 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Group S	Experimental	Device: Washing Pipe With a Spray NozzleGroup S patients will receive topical lidocaine anesthesia via the spray nozzle by the spray as-you-go technique during flexible bronchoscopy.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Washing Pipe With a Spray NozzleAdministration of topical airway anesthesia via a washing pipe with a spray nozzle using the spray-as-you-go technique	Device	Group S

Primary outcome

Cough rate
Time frame: Through the duration of the bronchoscopy exam, an average of 30 min
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.

5 secondary outcomes

Procedure time
Time frame: Through the duration of the bronchoscopy exam, an average of 30 min
Lidocaine dosage
Time frame: Through the duration of the bronchoscopy exam, an average of 30 min
Patient tolerance
Time frame: Through the duration of the bronchoscopy exam, an average of 30 min
Patient satisfaction
Time frame: Through the duration of the bronchoscopy exam, an average of 30 min
Adverse events
Time frame: Through the duration of the bronchoscopy exam, an average of 30 min

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
Background: PubMed 23860341Du 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.
Background: PubMed 32023078Criner 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.
Background: PubMed 32445309Mohan 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.
Background: PubMed 29487243Madan 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.
Background: PubMed 22045879Wahidi 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.
Background: PubMed 35655299Kim 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.
Background: PubMed 30521615Fujimoto 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.
Background: PubMed 22074355Ling 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.
Background: PubMed 19703068Antoniades 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.
Background: PubMed 35441943Cai 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.
Background: PubMed 32883896Venkatnarayan 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.
Background: PubMed 28435314Yildirim 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chao-Chi Ho, MD, PhD principal investigator

National Taiwan University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Washing Pipe With a Spray Nozzle in people with Pulmonary Disease, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cough rate (time frame: Through the duration of the bronchoscopy exam, an average of 30 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05970848, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024; AzTrials last refreshed its copy on 2 Nov 2026.