Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04025918
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2019-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}, {'id': 'D004809', 'term': 'Ephedrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypotension', 'timeFrame': '1 day', 'description': 'Incidence of systolic blood pressure less than 80% of baseline systolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'Hypertension', 'timeFrame': '1 day', 'description': 'Incidence of systolic blood pressure more than 120% of baseline systolic blood pressure'}, {'measure': 'Nausea and vomiting', 'timeFrame': '1 day', 'description': 'Incidence of nausea and vomiting during cesarean section'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypotension', 'spinal anesthesia', 'cesarean section', 'phenylephrine', 'ephedrine', 'closed-loop system', 'continuous non-invasive monitor'], 'conditions': ['Hypotension']}, 'referencesModule': {'references': [{'pmid': '20173633', 'type': 'BACKGROUND', 'citation': 'Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6.'}, {'pmid': '23020653', 'type': 'BACKGROUND', 'citation': 'Sia AT, Tan HS, Sng BL. Closed-loop double-vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: a preliminary study. Anaesthesia. 2012 Dec;67(12):1348-55. doi: 10.1111/anae.12000. Epub 2012 Sep 28.'}, {'pmid': '24256483', 'type': 'RESULT', 'citation': 'Sng BL, Tan HS, Sia AT. Closed-loop double-vasopressor automated system vs manual bolus vasopressor to treat hypotension during spinal anaesthesia for caesarean section: a randomised controlled trial. Anaesthesia. 2014 Jan;69(1):37-45. doi: 10.1111/anae.12460. Epub 2013 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'Hypotension occurs commonly during spinal anesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure monitoring (CNAP, CNSystems, Austria).', 'detailedDescription': 'Hypotension occurs commonly during spinal anesthesia for cesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure (CNAP, CNSystems, Austria) monitoring feeding hemodynamic data to a laptop computer, which triggers syringe pumps to deliver phenylephrine 50mcg or ephedrine 4mg (if heart rate\\<60 beats.min-1) every 30 seconds when systolic blood pressure fell to below 90% of baseline.\n\nA randomised controlled trial was done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 100mcg or ephedrine 8mg (if heart rate\\<60 beats.min-1) was given every 60 seconds by the attending anesthesiologist when systolic blood pressure was below 90% of baseline as measured by conventional intermittent non-invasive blood pressure monitoring.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Study participants need to be pregnant and undergoing elective cesarean section', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 21-45 years old,\n* weight 40-90 kg,\n* height 145-170 cm\n\nExclusion Criteria:\n\n* contraindications to spinal anaesthesia,\n* allergy to drugs used in the study, and\n* those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT04025918', 'briefTitle': 'Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section', 'orgStudyIdInfo': {'id': '2010/365/D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vasopressor delivery automated system', 'description': 'vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor', 'interventionNames': ['Device: Vasopressor automated delivery system', 'Drug: Phenylephrine', 'Drug: Ephedrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'manual vasopressor delivery', 'description': 'manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor', 'interventionNames': ['Drug: Phenylephrine', 'Drug: Ephedrine', 'Device: Manual vasopressor delivery system']}], 'interventions': [{'name': 'Vasopressor automated delivery system', 'type': 'DEVICE', 'otherNames': ['CNAP'], 'description': 'Novel closed-loop system incorporating:\n\n1. Continuous non-invasive arterial pressure (CNAP) monitor that measured and recorded hemodynamic data in real time.\n2. Controller algorithm loaded onto a laptop computer that monitored the hemodynamic data from CNAP and determined if vasopressors should be administered.\n3. Two syringe pumps loaded with phenylephrine and ephedrine that was activated by the controller algorithm.', 'armGroupLabels': ['vasopressor delivery automated system']}, {'name': 'Phenylephrine', 'type': 'DRUG', 'description': "Phenylephrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of at least 60bpm.", 'armGroupLabels': ['manual vasopressor delivery', 'vasopressor delivery automated system']}, {'name': 'Ephedrine', 'type': 'DRUG', 'description': "Ephedrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of less than 60bpm.", 'armGroupLabels': ['manual vasopressor delivery', 'vasopressor delivery automated system']}, {'name': 'Manual vasopressor delivery system', 'type': 'DEVICE', 'description': 'Manual dosing system consisting:\n\n1. Non-invasive intermittent blood pressure monitor that measured and recorded blood pressure at 1-minute intervals.\n2. Attending anesthesiologist that noted the blood pressure readings and manually administered phenylephrine or ephedrine according to the algorithm.', 'armGroupLabels': ['manual vasopressor delivery']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ban Leong Sng, FANZCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}