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Completed

NCT Number: NCT05970848

Washing Pipe with a Spray Nozzle for Topical Anesthesia During Bronchoscopy

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.

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Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Washing Pipe With a Spray Nozzle

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Procedure time

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

    The duration (minute) of the bronchoscopic procedure

  2. Lidocaine dosage

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

    Total lidocaine doses dispensed during the bronchoscopic procedure

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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