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临床试验/NCT06680648
NCT06680648尚未招募不适用

Oxygen Insufflation Via a Flexible Scope to Remove Secretions and Blood Obstructiong the View When Advancing the Scope Towrds the Trachea

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
试验地点
1
主要终点
The fraction of bronchoscopic advancements that result in a view of vocal cords (Fully or partial) without the view being obstructed by saliva or blood during the advancement

研究概览

简要总结

The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained

详细描述

The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"

排除标准

  • •non acceptance of participation

研究组 & 干预措施

Insufflation first followed by no-insufflation

Experimental

干预措施: addition of oxygeninsufflation via working channel of flexible scope (Procedure)

no-insufflation first followed by insufflation

Active Comparator

干预措施: no-oxygen insufflation (Procedure)

结局指标

主要结局

The fraction of bronchoscopic advancements that result in a view of vocal cords (Fully or partial) without the view being obstructed by saliva or blood during the advancement

时间窗: 90 seconds

The fraction in whom The flexible scope is advanced to the trachea with maintained visibility all the time until vocal cord is seen

次要结局

  • unobstructed advancement to the trachea in 90 seconds(90 seconds)
  • Duration until the tip of the scope is in the trachea(0-2 minutes)
  • Operation percieved ease of advancing the scope to the trachea with maintained visibility(2 minutes)
  • The scope is advanced to the trachea within 2 minutes(2 minutes)
  • Operation percieved ease of advancing the scope to the trachea, overall(2 minute)
  • The scope is advanced to the trachea within 1 minute(1 minute)
  • unobstructed advancement to the trachea in two minutes(2 minute)
  • Obtaining a view of vocal cord(s) without obstruction of the view, obtained in 30 seconds(30 sekunds)
  • Obtaining a view of vocal cord(s) without obstruction of the view, obtained in one minute(1 minute)
  • Obtaining a view of the vocal cord(s) without obstruction of the view, obtained in 90 seconds(90 seconds)
  • The fraction of brochoscopic advancements that results in Unobstructed advancement to the trachea in one minute(1 minute)

研究者

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

Michael Seltz Kristensen

Consultant anaesthesiologist

Rigshospitalet, Denmark

研究点 (1)

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