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临床试验/NCT05970848
NCT05970848已完成不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Cough rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Cough rate

时间窗: 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.

次要结局

  • Adverse events(Through the duration of the bronchoscopy exam, an average of 30 min)
  • Procedure time(Through the duration of the bronchoscopy exam, an average of 30 min)
  • Lidocaine dosage(Through the duration of the bronchoscopy exam, an average of 30 min)
  • Patient satisfaction(Through the duration of the bronchoscopy exam, an average of 30 min)
  • Patient tolerance(Through the duration of the bronchoscopy exam, an average of 30 min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Statistical Center, NTUHCTC

Clinical Professor

National Taiwan University Hospital

研究点 (1)

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