Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-01 @ 11:27 PM
Study NCT ID:
NCT03522493
Status:
UNKNOWN
Last Update Posted:
2018-05-11
First Post:
2016-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average CO2 (%)', 'timeFrame': '45 minutes', 'description': 'Average CO2 (%) will be measured continusly during each of the filters for the two groups.'}], 'secondaryOutcomes': [{'measure': 'Respiratory discomfort (borg scale 1-10)', 'timeFrame': '45 minutes', 'description': 'Respiratory discomfort will be measured using the Borg scale for each filters and for the two groups'}, {'measure': 'Average O2 (%)', 'timeFrame': '45 minutes', 'description': 'Average O2 (%) will be measured continusly during each of the filters for the two groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy 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\n\n\\-\n\nExclusion Criteria:\n\nDid 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.'}, 'identificationModule': {'nctId': 'NCT03522493', 'briefTitle': 'The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "', 'organization': {'class': 'OTHER', 'fullName': 'Medical Corps, Israel Defense Force'}, 'officialTitle': 'The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "Yaalom Katom"', 'orgStudyIdInfo': {'id': '1552-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Young group', 'description': 'This arm include 20 young subjects that will perform the same experiment as the old group for a comparison reasons.', 'interventionNames': ['Device: "Yaalom Katom"']}, {'type': 'EXPERIMENTAL', 'label': 'Old group', 'description': 'This group us the group of interest. This group will wear the mask and is expected to show differences from the younger group.', 'interventionNames': ['Device: "Yaalom Katom"']}], 'interventions': [{'name': '"Yaalom Katom"', 'type': 'DEVICE', 'description': 'Full face Gas mask', 'armGroupLabels': ['Old group', 'Young group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3109601', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Dror Ofir, PhD', 'role': 'CONTACT', 'email': 'meri_mehkar@bezeqint.net', 'phone': '972-4-8693525'}, {'name': 'Mirit Eynan, PhD', 'role': 'CONTACT', 'email': 'meri_mehkar@bezeqint.net', 'phone': '972-4-8693525', 'phoneExt': 'Eynan'}], 'facility': 'Israel Naval Medical Institute', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Dror Ofir, PhD', 'role': 'CONTACT', 'email': 'meri_mehkar@bezeqint.net', 'phone': '972-4-8693525'}, {'name': 'YEHUDA ARIELI, PhD', 'role': 'CONTACT', 'email': 'yarieli@netvision.net.il', 'phone': '972-4-8693527'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Corps, Israel Defense Force', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}