Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-05 @ 9:07 PM
Study NCT ID:
NCT04520893
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilation Strategy for the Elderly Patients in Prone Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-19', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MVCO2', 'timeFrame': 'ventilation 15 min later', 'description': 'minute CO2 production (ml/min), a parameter of Drager ventilator, displayed in the Primus model and software'}], 'secondaryOutcomes': [{'measure': 'airway pressure', 'timeFrame': 'ventilation 15 min later', 'description': 'peak airway pressure (cmH2O; displayed in the ventilator), plateau pressure (cmH2O; diaplayed in the ventilator), driving pressure(cmH2O, plateau pressure minus peak airway pressure)'}, {'measure': 'airway compliance', 'timeFrame': 'ventilation 15 min later', 'description': 'Respiratory dynamic compliance (ml/cmH2O; displayed in the ventilator)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['geriatric medicine, protective ventilation, prone position'], 'conditions': ['Ventilators, Mechanical']}, 'descriptionModule': {'briefSummary': 'The investigators compare three ventilation modes; volume controlled ventilation, volume guaranteed pressure controlled ventilation and volume controlled ventilation with pause during spine surgery for the elderly patients. The investigators can reveal that how lung collapse can be reduced by optimizing the inspiratory flow pattern under general anesthesia.', 'detailedDescription': '\\<Protocol\\>\n\n1. All patients were ventilated by an anaesthesia ventilator (Zeus, Dräger, Lübeck, Germany) under general anesthesia.\n2. Ventilation strategy:\n\n * Pressure controlled ventilation volume guaranteed (PCV-VG) mode or volume control ventilation (VCV) mode\n * tidal volume 6-8 mL/kg (predicted body weight)\n * Inspiratory/expiratory (I/E) ratio 1:1.5\n * Inspired oxygen concentration (FIO2) 0.5 with air\n * 3.0 L/min of inspiratory fresh gas flow\n * Positive end-expiratory pressure (PEEP) of 5 cm H2O\n * Respiratory rate (RR) of 10 to 14 min-1\n3. After prone positioning and hemodynamic condition was stabilized, patients were ventilated with VCV, PCV-VG mode, VCV with pause following a randomized order, previously determined for each patient. Before each ventilator setting was started, lung recruitment maneuvers were performed to set the lungs to a defined baseline status.\n\n * ventilation order : one of the following examples is taken by randomization.\n\nVCV 15 min -- VCV pause 15min -- PCV-VG 15min\n\nVCV 15 min -- PCV-VG 15min -- VCV pause 15min\n\nVCV pause 15min -- VCV 15 min -- PCV-VG 15min\n\nVCV pause 15min -- PCV-VG 15min -- VCV 15 min\n\nPCV-VG 15min -- VCV 15 min -- VCV pause 15min\n\nPCV-VG 15min -- VCV pause 15min -- VCV 15 min'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing elective spine surgery under general anesthesia\n\nExclusion Criteria:\n\n* obesity (body mass index \\>35 kg/m2)\n* chronic obstructive pulmonary disease\n* respiratory infection'}, 'identificationModule': {'nctId': 'NCT04520893', 'briefTitle': 'Ventilation Strategy for the Elderly Patients in Prone Position', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Kangnam Sacred Heart Hospital'}, 'officialTitle': 'Modification of Ventilation Strategy for the Elderly Patients During Spine Surgery in Prone Position', 'orgStudyIdInfo': {'id': '2020-03-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VCV pause', 'description': 'volume controlled ventilation with pause time 30%', 'interventionNames': ['Procedure: ventilator setting vcv with pause']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VCV', 'description': 'volume controlled ventilation (without pause)', 'interventionNames': ['Procedure: ventilator setting vcv']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCV-VG', 'description': 'pressure controlled ventilation - volume guaranteed', 'interventionNames': ['Procedure: ventilator setting pcv-vg']}], 'interventions': [{'name': 'ventilator setting vcv with pause', 'type': 'PROCEDURE', 'description': 'ventilator setting vcv with pause', 'armGroupLabels': ['VCV pause']}, {'name': 'ventilator setting vcv', 'type': 'PROCEDURE', 'description': 'ventilator setting vcv without pause', 'armGroupLabels': ['VCV']}, {'name': 'ventilator setting pcv-vg', 'type': 'PROCEDURE', 'description': 'ventilator setting with pcv-vg', 'armGroupLabels': ['PCV-VG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07441', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Kangnam Sacred Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Eunhee Chun, MD.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Kangnam Sacred Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunhee Chun', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Eunhee Chun', 'investigatorAffiliation': 'Hallym University Kangnam Sacred Heart Hospital'}}}}