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

2018年4月30日更新者：Medical Corps, Israel Defense Force

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

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.

研究概览

地位

未知

条件

老化

干预/治疗

设备："Yaalom Katom"

详细说明

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.

研究类型

介入性

注册 (预期的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

以色列
- - Haifa、以色列、3109601
    - 招聘中
    - Israel Naval Medical Institute
    - 接触：
      
      Dror Ofir, PhD
      
      电话号码：972-4-8693525
      
      邮箱：meri_mehkar@bezeqint.net
    - 接触：
      
      Mirit Eynan, PhD
      
      电话号码：Eynan 972-4-8693525
      
      邮箱：meri_mehkar@bezeqint.net

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：预防
分配：非随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Young group This arm include 20 young subjects that will perform the same experiment as the old group for a comparison reasons.	设备："Yaalom Katom" Full face Gas mask
实验性的：Old group This group us the group of interest. This group will wear the mask and is expected to show differences from the younger group.	设备："Yaalom Katom" Full face Gas mask

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Average CO2 (%) 大体时间：45 minutes	Average CO2 (%) will be measured continusly during each of the filters for the two groups.	45 minutes

次要结果测量

结果测量	措施说明	大体时间
Respiratory discomfort (borg scale 1-10) 大体时间：45 minutes	Respiratory discomfort will be measured using the Borg scale for each filters and for the two groups	45 minutes
Average O2 (%) 大体时间：45 minutes	Average O2 (%) will be measured continusly during each of the filters for the two groups.	45 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medical Corps, Israel Defense Force

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年7月1日

初级完成 (预期的)

2018年8月1日

研究完成 (预期的)

2018年8月1日

研究注册日期

首次提交

2016年4月7日

首先提交符合 QC 标准的

2018年4月30日

首次发布 (实际的)

2018年5月11日

研究记录更新

最后更新发布 (实际的)

2018年5月11日

上次提交的符合 QC 标准的更新

2018年4月30日

最后验证

2018年4月1日

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