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临床试验/NCT06802744
NCT06802744Enrolling By Invitation不适用

Changes in Systemic Carbon Dioxide Levels During Simulated Avalanche Burial Using a One-way Valve Device: a Double Blinded, Randomized Cross-over Trial

Klinik fur Pneumologie und Schlafmedizin Kantonsspital Aarau2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年2月7日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
10
试验地点
2
主要终点
Course of PtCO2 measured transcutaneously

研究概览

简要总结

Every year, around 100 people die in avalanches in the Alps. Many of these accidents occur during winter sports. In most cases, the victims suffocate under the snow after the avalanche has come to a standstill. A key survival factor here is the time it takes to be rescued. If a buried victim is rescued within 15 minutes, the probability of survival is over 90%. After 35 minutes, however, this drops drastically to just 30%.

A modern avalanche rescue system, such as the AvaLung-device, could extend the survival time. The system directs the exhaled air via a tube to the back of the buried person so that no toxic CO2 concentrations build up in the available breathing cavity. It is also intended to prevent the formation of an "ice mask", which can impair the release of oxygen from the snow. This study investigates whether the AvaLung system can extend the survival time in the event of burial.

The aim is to test the effects of such a breathing tube system. The oxygen and carbon dioxide levels of the test subjects are measured while they are buried in a simulated avalanche - once with and once without the AvaLung system. In addition, it is investigated how long it takes before the buried subjects have to stop the examination, for example due to shortness of breath or deteriorating respiratory gases in the blood.

Test setup:

The test subjects lie on their backs with their heads and chests buried under snow. During the test phase, various parameters are continuously monitored, such as the breathing rate and the CO2 concentration in the blood. A comparative study is carried out: once with a functioning rescue system, and once with a manipulated (non-functioning) system.

Expected benefit:

The results of this study should contribute to a better understanding of the effectiveness of avalanche rescue systems and thus increase the chances of survival of avalanche victims in the future. This is particularly important today, as the number of winter sports enthusiasts and the number of avalanches triggered by them is constantly increasing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over 18
  • Able to consent

排除标准

  • Anamnestic evidence of previous pulmonary or cardiac disease
  • Known neuromuscular diseases
  • Thoracic deformities
  • Acute respiratory infections
  • In women: Pregnancy (excluded by history and urine test)
  • Age over 60 Years
  • Presence of claustrophobia

结局指标

主要结局

Course of PtCO2 measured transcutaneously

时间窗: 45 minutes

次要结局

  • Burial time until the test is terminated(45 minutes)
  • Course of PetCO2(45 minutes)
  • Progression of respiratory minute volume(45 minutes)
  • Course of the body temperature(45 minutes)
  • Heart rate progression and variability(45 minutes)
  • Course of PtO2(45 minutes)
  • Course of PetO2(45 minutes)
  • Course of SpO2(45 minutes)
  • Progression of Respiratory rate(45 minutes)

研究者

发起方
Klinik fur Pneumologie und Schlafmedizin Kantonsspital Aarau
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Hans-Joachim Kabitz

Prof. Dr. med.

Kantonsspital Aarau

研究点 (2)

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