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临床试验/NCT03082105
NCT03082105已完成不适用

Evaluation of Air Pocket Factors That Contribute to the Development of Hypoxia and Hypercapnia

Institute of Mountain Emergency Medicine2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
SpO2 (%)

研究概览

简要总结

Sufficient oxygenation is critical for completely buried avalanche victims to avoid life-threatening consequences during hypoxic exposure. Snow contains a remarkable capacity to maintain air availability; it was suspected that the snow physical properties affect the development of hypoxia and hypercapnia. The aim of this study was to evaluate the influence of different snow physical properties on the development of hypoxia and hypercapnia in subjects breathing into an artificial air pocket in snow. Twelve male healthy subjects breathed through an airtight face-mask and 40cm tube into an artificial air pocket of 4L. Every subject performed three tests on different days with varying snow characteristics. Symptoms, gas and cardiovascular parameters were monitored up to 30min. Tests were interrupted at SpO2 <75% (primary endpoint); or due to subjective symptoms like dyspnea, dizziness, and headache (i.e. related to hypercapnia). Snow density was assessed via standard methods and micro-computed tomography (CT) analysis, and permeability and penetration with the snow micro-penetrometer (SMP).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers with an age above 18yr-old, physically active.
  • Volunteers have been informed and have signed consent.

排除标准

  • Lack of consent.
  • Chronic previous illness of the respiratory tract or of the cardiovascular system.
  • Acute disease at or immediately prior to the test (eg, flu-like infection, fever of unknown origin).
  • Eurac employees.

结局指标

主要结局

SpO2 (%)

时间窗: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase

Continuous monitoring

次要结局

  • VE (L/min)(Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase)
  • EtCO2 (mmHg)(Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase)
  • Cause of interruption(Timepoint immediately before interruption of snow-breathing phase (max 30min))
  • rSO2 (%)(Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase)

研究者

发起方
Institute of Mountain Emergency Medicine
申办方类型
Other
责任方
Sponsor

研究点 (2)

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