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Washing Pipe With a Spray Nozzle for Topical Anesthesia During Bronchoscopy

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05970848
Collaborator
(none)
126
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Washing Pipe With a Spray Nozzle
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant, Outcomes 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.
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cough rate [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.

Secondary Outcome Measures

  1. Procedure time [Through the duration of the bronchoscopy exam, an average of 30 min]

    The duration (minute) of the bronchoscopic procedure

  2. Lidocaine dosage [Through the duration of the bronchoscopy exam, an average of 30 min]

    Total lidocaine doses dispensed during the bronchoscopic procedure

  3. Patient tolerance [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

  4. Patient satisfaction [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

  5. Adverse events [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chao-Chi Ho, MD, PhD, Clinical Professor, National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05970848
Other Study ID Numbers:
  • 202302060RINC
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chao-Chi Ho, MD, PhD, Clinical Professor, National Taiwan University Hospital
flexible bronchoscopy
topical airway anesthesia
Additional relevant MeSH terms:
Lung Diseases

Study Results

No Results Posted as of Aug 1, 2023