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

Not Applicable

• Conditions: Aging
• Interventions: Device: "Yaalom Katom"

• Registration Number: NCT03522493
• Lead Sponsor: Medical Corps, Israel Defense Force

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.

Study Timeline

• Study First Submitted: 2016-04-07
• Study Start: 2016-07
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-30
• Last Update Submitted: 2018-04-30
• Study First Posted: 2018-05-11
• Last Update Posted: 2018-05-11
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Old group	"Yaalom Katom"	This group us the group of interest. This group will wear the mask and is expected to show differences from the younger group.
Young group	"Yaalom Katom"	This arm include 20 young subjects that will perform the same experiment as the old group for a comparison reasons.

Primary Outcome Measures

Name	Time	Method
Average CO2 (%)	45 minutes	Average CO2 (%) will be measured continusly during each of the filters for the two groups.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Israel Naval Medical Institute; 🇮🇱 Haifa, Israel