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

Primary Purpose

Aging

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
"Yaalom Katom"
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Israel Naval Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Young group

Old group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Respiratory discomfort (borg scale 1-10)
Respiratory discomfort will be measured using the Borg scale for each filters and for the two groups
Average O2 (%)
Average O2 (%) will be measured continusly during each of the filters for the two groups.

Full Information

First Posted
April 7, 2016
Last Updated
April 30, 2018
Sponsor
Medical Corps, Israel Defense Force
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1. Study Identification

Unique Protocol Identification Number
NCT03522493
Brief Title
The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "
Official Title
The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "Yaalom Katom"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Corps, Israel Defense Force

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Young group
Arm Type
Active Comparator
Arm Description
This arm include 20 young subjects that will perform the same experiment as the old group for a comparison reasons.
Arm Title
Old group
Arm Type
Experimental
Arm Description
This group us the group of interest. This group will wear the mask and is expected to show differences from the younger group.
Intervention Type
Device
Intervention Name(s)
"Yaalom Katom"
Intervention Description
Full face Gas mask
Primary Outcome Measure Information:
Title
Average CO2 (%)
Description
Average CO2 (%) will be measured continusly during each of the filters for the two groups.
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Respiratory discomfort (borg scale 1-10)
Description
Respiratory discomfort will be measured using the Borg scale for each filters and for the two groups
Time Frame
45 minutes
Title
Average O2 (%)
Description
Average O2 (%) will be measured continusly during each of the filters for the two groups.
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dror Ofir, PhD
Phone
972-4-8693525
Email
meri_mehkar@bezeqint.net
First Name & Middle Initial & Last Name or Official Title & Degree
YEHUDA ARIELI, PhD
Phone
972-4-8693527
Email
yarieli@netvision.net.il
Facility Information:
Facility Name
Israel Naval Medical Institute
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dror Ofir, PhD
Phone
972-4-8693525
Email
meri_mehkar@bezeqint.net
First Name & Middle Initial & Last Name & Degree
Mirit Eynan, PhD
Phone
972-4-8693525
Ext
Eynan
Email
meri_mehkar@bezeqint.net

12. IPD Sharing Statement

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