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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03522493
• Other study ID #: 1552-2015
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: April 2018
• Source: Medical Corps, Israel Defense Force
• Contact: Dror Ofir, PhD
• Phone: 972-4-8693525
• Email: meri_mehkar[@]bezeqint.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Respiratory Aspiration

Intervention

Device:
• "Yaalom Katom"
Full face Gas mask

Locations

Country	Name	City	State
Israel	Israel Naval Medical Institute	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average CO2 (%)	Average CO2 (%) will be measured continusly during each of the filters for the two groups.	45 minutes
Secondary	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
Secondary	Average O2 (%)	Average O2 (%) will be measured continusly during each of the filters for the two groups.	45 minutes