Washing Pipe with a Spray Nozzle for Topical Anesthesia During Bronchoscopy

October 17, 2024 updated by: Statistical Center, NTUHCTC, National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group S
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
Administration of topical airway anesthesia via a washing pipe with a spray nozzle using the spray-as-you-go technique
No Intervention: Group C
Group C patients will receive topical lidocaine anesthesia with the conventional method by the spray as-you-go technique during flexible bronchoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through the duration of the bronchoscopy exam, an average of 30 min

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Chao-Chi Ho, MD, PhD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

July 30, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 17, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202302060RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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