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临床试验/NCT03522493
NCT03522493Unknown不适用

The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "Yaalom Katom"

Medical Corps, Israel Defense Force1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Average CO2 (%)

研究概览

简要总结

20 healthy young subjects and 20 healthy older subjects will go through a medical examination. Subjects will be asked for their medical history especially on respiratory and cardiac diseases. All subjects will go through a spirometry test to evaluate their respiratory function. After their medical clearance each subjects will be asked to wear a CBRN respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmH2O resistance, and 15 minutes with 1.2 cmH2O resistance. Throughout the test, Pco2 AND PO2 will be measured. The investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on CO2 accumulation in the mask.

详细描述

After signing the consent form, 20 healthy young subjects and 20 healthy older subjects will go through a medical examination. Subjects will be asked for their medical history especially on respiratory and cardiac diseases. All subjects will go through a spirometry test to evaluate their respiratory function. After their medical clearance each subjects will be asked to wear a CBRN respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmH2O resistance, and 15 minutes with 1.2 cmH2O resistance. Throughout the test, Pco2 AND PO2 will be measured with mass spectrometer. Oxygen saturation, Pulse rate, and minute ventilation will also be monitored. The investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on CO2 accumulation in the mask.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy females and males, with no respiratory, cardio vascular diseases, high blood pressure, psychiatric problem, degenerative nervous system problem, and chronic head ache, muscular disease, or severe acute disease within the two weeks before the study. age 18 and 25, and 55 and 70 years old. Who volunteer to the study

排除标准

  • •Did not pass the Inclusion criteria, pregnant women, O2 saturation lower then 95%, pathological sound from the heart or lungs. Claustrophobia, smoking history more then 2.5 packs years.

研究组 & 干预措施

Young group

Active Comparator

This arm include 20 young subjects that will perform the same experiment as the old group for a comparison reasons.

干预措施: "Yaalom Katom" (Device)

Old group

Experimental

This group us the group of interest. This group will wear the mask and is expected to show differences from the younger group.

干预措施: "Yaalom Katom" (Device)

结局指标

主要结局

Average CO2 (%)

时间窗: 45 minutes

Average CO2 (%) will be measured continusly during each of the filters for the two groups.

次要结局

  • Respiratory discomfort (borg scale 1-10)(45 minutes)
  • Average O2 (%)(45 minutes)

研究者

发起方
Medical Corps, Israel Defense Force
申办方类型
Other
责任方
Sponsor

研究点 (1)

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