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

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.

Study Overview

• Status: Unknown
• Conditions: Aging
• Intervention / Treatment: Device: "Yaalom Katom"

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dror Ofir, PhD; Phone Number: 972-4-8693525; Email: meri_mehkar@bezeqint.net
• Study Contact Backup: Name: YEHUDA ARIELI, PhD; Phone Number: 972-4-8693527; Email: yarieli@netvision.net.il

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Israel Naval Medical Institute
    • Contact: Dror Ofir, PhD; Phone Number: 972-4-8693525; Email: meri_mehkar@bezeqint.net
    • Contact: Mirit Eynan, PhD; Phone Number: Eynan 972-4-8693525; Email: meri_mehkar@bezeqint.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Young group; This arm include 20 young subjects that will perform the same experiment as the old group for a comparison reasons.	Device: "Yaalom Katom"; Full face Gas mask
Experimental: 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.	Device: "Yaalom Katom"; Full face Gas mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average CO2 (%)	Average CO2 (%) will be measured continusly during each of the filters for the two groups.	45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory discomfort (borg scale 1-10)	Respiratory discomfort will be measured using the Borg scale for each filters and for the two groups	45 minutes
Average O2 (%)	Average O2 (%) will be measured continusly during each of the filters for the two groups.	45 minutes

Collaborators and Investigators

• Sponsor: Medical Corps, Israel Defense Force

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 1552-2015