Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-01 @ 10:51 PM
Study NCT ID:
NCT06076057
Status:
UNKNOWN
Last Update Posted:
2023-10-10
First Post:
2023-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vital Signs Monitoring of Emergency Responders in Different States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'respiratory rate', 'timeFrame': '3 month', 'description': 'Breaths per minute'}, {'measure': 'heart rate', 'timeFrame': '3 month', 'description': 'beats per minute'}, {'measure': 'blood oxygen saturation', 'timeFrame': '3 month', 'description': 'Concentration of oxygen in the blood'}, {'measure': 'electromyography', 'timeFrame': '3 month', 'description': 'Measurement and analysis of electromyographic signals emitted during muscle contraction'}, {'measure': 'electroencephalogram', 'timeFrame': '3 month', 'description': 'Collecting brainwave signalsļ¼Analyze the EEG for abnormalities'}, {'measure': 'Partial pressure of end-expiratory CO2 concentration', 'timeFrame': '3 month', 'description': 'Measurement of the partial pressure of CO2 in exhaled gas at the end of expiration'}, {'measure': 'transcutaneous partial pressure of oxygen', 'timeFrame': '3 month', 'description': 'Measurement of the partial pressure of oxygen at the skin surface, thus indirectly reflecting the state of tissue oxygenation'}, {'measure': 'Percutaneous carbon dioxide partial pressure', 'timeFrame': '3 month', 'description': 'Indirectly reflecting the partial pressure of carbon dioxide by measuring the pH of the skin surface'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vital Signs', 'Respiration', 'transcutaneous oxygenation', 'end-expiratory carbon dioxide'], 'conditions': ['Heart Rate Monitoring']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about emergency responder in different states. The main questions it aims to answer are:\n\n* Ten vital signs and behavioral parameters in different states (quiet, after post, after physical training) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.\n* Eight vital signs and behavioral parameters in different environments (altitude, confined space, energized work, job site) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration.\n\nParticipants will normal operating conditions, the researcher collects vital sign information.', 'detailedDescription': '1. General information: name, age, height, weight, place of origin, smoking history, and whether or not they snore.\n2. 10 vital signs and behavioral parameters in different states (quiet, after duty, after physical training), including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, partial pressure of transcutaneous carbon dioxide.\n3. 8 vital signs and behavioral parameters in different environments (overhead, confined space, energized work, work site), including: respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Frontline National Grid Emergency Responders', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No history of coronary heart disease, hypertension, asthma, upper respiratory tract infection, decompression sickness, or anemia.\n\nVoluntarily participated in this study and signed an informed consent form\n\nExclusion Criteria:\n\n* Patients with severe heart disease and arrhythmia; patients with vital organ failure; patients with significant generalized edema; patients with dermatologic disease and generalized skin breakdown; and patients with vascular disorders of the limbs.'}, 'identificationModule': {'nctId': 'NCT06076057', 'briefTitle': 'Vital Signs Monitoring of Emergency Responders in Different States', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Vital Signs Monitoring of Emergency Responders in Different States', 'orgStudyIdInfo': {'id': '2021CXGC011301'}}, 'armsInterventionsModule': {'armGroups': [{'label': '8:00 Measurement team', 'description': 'At 08:00 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.', 'interventionNames': ['Diagnostic Test: vital signs monitoring']}, {'label': '10:30 Measurement team', 'description': 'At 10:30 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.', 'interventionNames': ['Diagnostic Test: vital signs monitoring']}, {'label': '16:30 Measurement team', 'description': 'At 16:30 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.', 'interventionNames': ['Diagnostic Test: vital signs monitoring']}, {'label': 'high altitude environment', 'description': 'In high altitude environments, monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration', 'interventionNames': ['Diagnostic Test: vital signs monitoring']}, {'label': 'limited space', 'description': 'In limited space environments, monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration', 'interventionNames': ['Diagnostic Test: vital signs monitoring']}, {'label': 'electrified operation', 'description': 'In electrified operation , monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration', 'interventionNames': ['Diagnostic Test: vital signs monitoring']}, {'label': 'work site', 'description': 'In work site , monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration', 'interventionNames': ['Diagnostic Test: vital signs monitoring']}], 'interventions': [{'name': 'vital signs monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors', 'armGroupLabels': ['10:30 Measurement team', '16:30 Measurement team', '8:00 Measurement team', 'electrified operation', 'high altitude environment', 'limited space', 'work site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li yang', 'role': 'CONTACT', 'email': 'ly974122@163.com', 'phone': '15688880756'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Ma dedong', 'role': 'CONTACT', 'email': 'ma@qiluhuxi.com', 'phone': '18560082806'}], 'overallOfficials': [{'name': 'luan xiaorong', 'role': 'STUDY_CHAIR', 'affiliation': 'Shandong University Qilu Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}