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临床试验/NCT03205826
NCT03205826已完成不适用

Measuring Collateral Ventilation Using Chartis® to Select Patients With Severe Emphysema for Endobronchial Valve Treatment: Conscious Sedation Versus General Anesthesia

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月1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
30
试验地点
1
主要终点
Failure rate

研究概览

简要总结

Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar collateral ventilation during bronchoscopy. Assessing collateral ventilation is important when you intend to treat a patient with endobronchial valves. Chartis measurement of collateral ventilation can be performed under both conscious sedation as well as general anesthesia. There is no consensus on what is the preferred method of anesthesia for Chartis measurements in the literature.

Objective: In this project we want to investigate whether there is a difference in Chartis measurement outcomes between these two methods of anesthesia: conscious sedation and general anesthesia.

Study design: This study will be a single center observational study

Study population: The study population exists of patients with severe emphysema who undergo collateral ventilation assessment before bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

Intervention: All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia.

Main study parameters/endpoints: Our primary outcome measure is the failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
  • Patient has provided signed informed consent.

排除标准

  • For safety reasons patients that meet the following criteria will not be included in this study:
  • RV/TLC>70%
  • RVSP>40mmHg
  • Known intolerance to Lidocaine
  • Any other medical reason/condition that warrants a short procedure (physician judgement )

结局指标

主要结局

Failure rate

时间窗: Baseline

The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.

次要结局

  • Influence collateral ventilation status on outcome(Baseline)
  • Chartis measurement duration(Baseline)
  • Physician feasibility(Baseline)
  • Influence severity on outcome(Baseline)

研究者

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

Dirk-Jan Slebos

MD PhD

University Medical Center Groningen

研究点 (1)

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