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Washing Pipe With a Spray Nozzle for Topical Anesthesia During Bronchoscopy

Primary Purpose

Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Washing Pipe With a Spray Nozzle
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Disease focused on measuring flexible bronchoscopy, topical airway anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 years or older A planned flexible bronchoscopy Being able to communicate with Mandarin Chinese or Taiwanese Hokkien Exclusion Criteria: are unwilling to join the study have tracheostomy or are intubated will receive intravenous anesthesia during flexible bronchoscopy known to be pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group S

    Group C

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 24, 2023
    Last Updated
    July 30, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05970848
    Brief Title
    Washing Pipe With a Spray Nozzle for Topical Anesthesia During Bronchoscopy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Disease
    Keywords
    flexible bronchoscopy, topical airway anesthesia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group S
    Arm Type
    Experimental
    Arm Description
    Group S patients will receive topical lidocaine anesthesia via the spray nozzle by the spray as-you-go technique during flexible bronchoscopy.
    Arm Title
    Group C
    Arm Type
    No Intervention
    Arm Description
    Group C patients will receive topical lidocaine anesthesia with the conventional method by the spray as-you-go technique during flexible bronchoscopy.
    Intervention Type
    Device
    Intervention Name(s)
    Washing Pipe With a Spray Nozzle
    Intervention Description
    Administration of topical airway anesthesia via a washing pipe with a spray nozzle using the spray-as-you-go technique
    Primary Outcome Measure Information:
    Title
    Cough rate
    Description
    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.
    Time Frame
    Through the duration of the bronchoscopy exam, an average of 30 min
    Secondary Outcome Measure Information:
    Title
    Procedure time
    Description
    The duration (minute) of the bronchoscopic procedure
    Time Frame
    Through the duration of the bronchoscopy exam, an average of 30 min
    Title
    Lidocaine dosage
    Description
    Total lidocaine doses dispensed during the bronchoscopic procedure
    Time Frame
    Through the duration of the bronchoscopy exam, an average of 30 min
    Title
    Patient tolerance
    Description
    Using a visual analogue scale from 0 to 10 to indicate patient tolerance of the bronchoscopy
    Time Frame
    Through the duration of the bronchoscopy exam, an average of 30 min
    Title
    Patient satisfaction
    Description
    Using a visual analogue scale from 0 to 10 to indicate patient satisfaction of the bronchoscopy
    Time Frame
    Through the duration of the bronchoscopy exam, an average of 30 min
    Title
    Adverse events
    Description
    Development of adverse events during the bronchoscopic procedure, such as bleeding and oxygen desaturation
    Time Frame
    Through the duration of the bronchoscopy exam, an average of 30 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or older A planned flexible bronchoscopy Being able to communicate with Mandarin Chinese or Taiwanese Hokkien Exclusion Criteria: are unwilling to join the study have tracheostomy or are intubated will receive intravenous anesthesia during flexible bronchoscopy known to be pregnant
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chou Hsiao-Chen
    Phone
    0972651146
    Email
    jillishere95@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chao-Chi Ho, MD, PhD
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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