Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-02-12 @ 4:34 AM
Study NCT ID:
NCT02657733
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2015-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study Between Nellcor Respiration Rate Technology (RRoxi) and Masimo Acoustic Respiration Rate (RRa)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2016-01-13', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The influence of different breathing rates (normal breathing, tachypnea, and bradypnea) on the accuracy of respiratory rate in breaths per minute as measured by the tested devices compared to a reference device.', 'timeFrame': '6 hours', 'description': 'Respiratory rate will be measured with the monitors (Radical-7 device, Nellcor device, Capnostream20p device) and recorded in the following units: Breath/minute. Differences in accuracy as compared to the reference device and differences in percentage of time in which the device was accurate will be analyzed offline.'}], 'secondaryOutcomes': [{'measure': 'The influence of hearing or performing noises on the accuracy of respiratory rates (in breaths per minute) as measured by the tested devices compared to a reference device.', 'timeFrame': '6 months', 'description': 'Respiratory rate will be measured with the monitors (Radical-7 device ,Nellcor device, Capnostream20p device) in breaths per minute. Differences in accuracy as compared to the reference device and differences in percentage of time in which the device indicated respiratory rate values will be analyzed offline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory Conditions for Adults'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Respiration rate is a critical vital sign that provides early detection of respiratory compromise and patient distress. Continuous monitoring of respiration rate is performed in patients under different clinical conditions, including post-surgery or different respiratory diseases. Clinician observation, pulse oximetry, and capnography are used individually or in combination to monitor ventilation during sedation and on post-surgical patients. The American Society of Anesthesiologists mandates the monitoring of respiration by measuring end tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques for respiration rate measurement include different technologies such as acoustic respiratory rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain respiratory conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Without Clinical diagnosis of chronic obstructive pulmonary disease (COPD)\n* Without Clinical diagnosis of heart disease.\n\nExclusion Criteria:\n\n* Want to be excluded\n* Breathing difficulties\n* Unabling or unwilling to follow the protocol.\n* Contact allergy to the adhesive neck sensor.'}, 'identificationModule': {'nctId': 'NCT02657733', 'briefTitle': 'Comparison Study Between Nellcor Respiration Rate Technology (RRoxi) and Masimo Acoustic Respiration Rate (RRa)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Comparison Study Between Nellcor Respiration Rate Technology (RRoxi) and Masimo Acoustic Respiration Rate (RRa)', 'orgStudyIdInfo': {'id': '10144939'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy volunteers', 'description': 'Respiration rate will be measured using several medical devices: Radical-7, Capnostream20p and Nellcor Bedside Respiratory Patient Monitoring System', 'interventionNames': ['Device: Radical-7', 'Device: Nellcor™ Bedside Respiratory Patient Monitoring System', 'Device: Capnostream 20p']}], 'interventions': [{'name': 'Radical-7', 'type': 'DEVICE', 'description': 'Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time.\n\nRadical-7- measures respiratory rate according to acoustic respiratory rate (RRa).', 'armGroupLabels': ['Healthy volunteers']}, {'name': 'Nellcor™ Bedside Respiratory Patient Monitoring System', 'type': 'DEVICE', 'description': 'Comparison between 3 different monitors that measure repiratory rate. The participant is connected to 3 monitors at the same time.\n\nNellcor™ Bedside Respiratory Patient Monitoring System - measures respiratory rate according to oximetry respiration rate (RRoxi).', 'armGroupLabels': ['Healthy volunteers']}, {'name': 'Capnostream 20p', 'type': 'DEVICE', 'description': 'Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Capnostream 20p- measures respiratory rate according to Capnography (RRetco2).', 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91035', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Herzog Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Michal Eisenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzog Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oridion', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Herzog Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}