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临床试验/NCT02237651
NCT02237651已完成不适用

Topical Nasopharyngeal Anesthesia in Outpatient Bronchoscopy

Hannover Medical School1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
252
试验地点
1
主要终点
Equally

研究概览

简要总结

The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.

详细描述

Patients included in the first half of the study (topical anesthesia with the Laryngeal atomizer) and with need for another bronchoscopy in the second half of the study (topical anesthesia with the Intranasal Mucosal Atomization Device) will be asked to repeat the questionnaire after the second bronchoscopy to allow in-patient comparison.

Description of the primary efficacy analysis and population:

The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients after lung transplantation (single, double or combined)
  • Informed consent
  • outpatient bronchoscopy

排除标准

  • Oxygen requirement at rest
  • Need for peri-interventional sedation
  • limited German language skills or other reasons which might impair patient communication or computer handling

结局指标

主要结局

Equally

时间窗: 30 min.

The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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