Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04752904
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized double blind controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-26', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hypotension by individualized methods', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Hypotension was defined as: SBP\\<80% of baseline SBP'}], 'secondaryOutcomes': [{'measure': 'Incidence of hypotension by standard methods', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Hypotension was defined as MBP\\<65mmHg'}, {'measure': 'Time-weighted average SBP<80% of baseline SBP', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Time-weighted average SBP\\<80% of baseline SBP'}, {'measure': 'Time-weighted average MAP <65mmHg', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Time-weighted average MAP \\<65mmHg'}, {'measure': 'Incidence of intraoperative severe hypotension', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Defined as: SBP \\< 70% of baseline SBP'}, {'measure': 'Incidence of intraoperative symptomatic hypotension', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness'}, {'measure': 'Incidence of nausea, vomiting, dizziness, breathlessness', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Incidence of nausea, vomiting, dizziness, breathlessness'}, {'measure': 'Incidence of intraoperative Hypertension', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'SBP\\> 120% of baseline SBP'}, {'measure': 'Maximum, Minimum recorded SBP, DBP, MBP', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Maximum, Minimum recorded SBP, DBP, MBP'}, {'measure': 'Cumulative duration of hypotension', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Cumulative duration of hypotension'}, {'measure': 'Number of hypotensive episodes', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Number of hypotensive episodes'}, {'measure': 'Onset time of hypotension', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Onset time of hypotension'}, {'measure': 'Cumulative consumptions of vasopressors', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Cumulative consumptions of vasopressors'}, {'measure': 'Incidence of bradycardia', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'HR (heart rate) \\<50 bpm'}, {'measure': 'Incidence of atropine use', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Incidence of atropine use'}, {'measure': 'Minimum heart rate', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Minimum heart rate'}, {'measure': 'Cardiac output, stroke volume', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'only in ClearSight System group'}, {'measure': 'The analysis of the differences between the test method (ClearSight) and reference method', 'timeFrame': 'From spinal anesthesia to delivery', 'description': 'Bland-Altman analysis'}, {'measure': 'Apgar Score', 'timeFrame': 'at 1 minute after delivery and 5 minutes after delivery', 'description': '1 minute, 5 minutes'}, {'measure': 'Umbilical arterial blood', 'timeFrame': 'within 10 minutes after delivery', 'description': 'Arterial blood gas analysis results'}, {'measure': 'Umbilical arterial pH', 'timeFrame': 'within 10 minutes after delivery', 'description': '\\<7.2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['noninvasive continuous blood pressure monitoring'], 'conditions': ['Cesarean Section Complications', 'Hypotension']}, 'referencesModule': {'references': [{'pmid': '31977628', 'type': 'BACKGROUND', 'citation': 'Wei C, Qian J, Zhang Y, Chang X, Hu H, Xiao F. Norepinephrine for the prevention of spinal-induced hypotension during caesarean delivery under combined spinal-epidural anaesthesia: Randomised, double-blind, dose-finding study. Eur J Anaesthesiol. 2020 Apr;37(4):309-315. doi: 10.1097/EJA.0000000000001152.'}, {'pmid': '30335625', 'type': 'BACKGROUND', 'citation': 'Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.'}, {'pmid': '31531852', 'type': 'BACKGROUND', 'citation': 'Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.'}, {'pmid': '29090733', 'type': 'BACKGROUND', 'citation': 'Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.'}, {'pmid': '30267340', 'type': 'BACKGROUND', 'citation': 'Juri T, Suehiro K, Kimura A, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Impact of non-invasive continuous blood pressure monitoring on maternal hypotension during cesarean delivery: a randomized-controlled study. J Anesth. 2018 Dec;32(6):822-830. doi: 10.1007/s00540-018-2560-2. Epub 2018 Sep 28.'}, {'pmid': '27195632', 'type': 'BACKGROUND', 'citation': 'Bartels K, Esper SA, Thiele RH. Blood Pressure Monitoring for the Anesthesiologist: A Practical Review. Anesth Analg. 2016 Jun;122(6):1866-79. doi: 10.1213/ANE.0000000000001340.'}, {'pmid': '30649073', 'type': 'BACKGROUND', 'citation': 'Rogge DE, Nicklas JY, Schon G, Grothe O, Haas SA, Reuter DA, Saugel B. Continuous Noninvasive Arterial Pressure Monitoring in Obese Patients During Bariatric Surgery: An Evaluation of the Vascular Unloading Technique (Clearsight system). Anesth Analg. 2019 Mar;128(3):477-483. doi: 10.1213/ANE.0000000000003943.'}, {'pmid': '30562226', 'type': 'BACKGROUND', 'citation': 'Noto A, Sanfilippo F, De Salvo G, Crimi C, Benedetto F, Watson X, Cecconi M, David A. Noninvasive continuous arterial pressure monitoring with Clearsight during awake carotid endarterectomy: A prospective observational study. Eur J Anaesthesiol. 2019 Feb;36(2):144-152. doi: 10.1097/EJA.0000000000000938.'}, {'pmid': '32682556', 'type': 'BACKGROUND', 'citation': 'Ngan Kee WD, Lee SWY, Ng FF, Lee A. Norepinephrine or phenylephrine during spinal anaesthesia for Caesarean delivery: a randomised double-blind pragmatic non-inferiority study of neonatal outcome. Br J Anaesth. 2020 Oct;125(4):588-595. doi: 10.1016/j.bja.2020.05.057. Epub 2020 Jul 15.'}, {'pmid': '24740992', 'type': 'BACKGROUND', 'citation': 'Vos JJ, Poterman M, Mooyaart EA, Weening M, Struys MM, Scheeren TW, Kalmar AF. Comparison of continuous non-invasive finger arterial pressure monitoring with conventional intermittent automated arm arterial pressure measurement in patients under general anaesthesia. Br J Anaesth. 2014 Jul;113(1):67-74. doi: 10.1093/bja/aeu091. Epub 2014 Apr 15.'}, {'pmid': '26401736', 'type': 'BACKGROUND', 'citation': 'Lawicka M, Malek A, Antczak D, Wajlonis A, Owczuk R. Non-invasive haemodynamic measurements with Nexfin predict the risk of hypotension following spinal anaesthesia. Anaesthesiol Intensive Ther. 2015;47(4):303-8. doi: 10.5603/AIT.2015.0048.'}, {'pmid': '22382920', 'type': 'BACKGROUND', 'citation': 'Chen G, Chung E, Meng L, Alexander B, Vu T, Rinehart J, Cannesson M. Impact of non invasive and beat-to-beat arterial pressure monitoring on intraoperative hemodynamic management. J Clin Monit Comput. 2012 Apr;26(2):133-40. doi: 10.1007/s10877-012-9344-2. Epub 2012 Mar 1.'}, {'pmid': '29511971', 'type': 'BACKGROUND', 'citation': 'Juri T, Suehiro K, Kimura A, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Impact of continuous non-invasive blood pressure monitoring on hemodynamic fluctuation during general anesthesia: a randomized controlled study. J Clin Monit Comput. 2018 Dec;32(6):1005-1013. doi: 10.1007/s10877-018-0125-4. Epub 2018 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'Noninvasive continuous blood pressure monitoring for preventing post-spinal hypotension during cesarean delivery: A randomized controlled trial', 'detailedDescription': 'The aim of this study was to find out whether the incidence of hypotension during surgery can be reduced in the case of non-invasive, continuous blood pressure monitoring using the ClearSight System in patients undergoing cesarean section under spinal anesthesia, compared to the case of using conventional noninvasive blood pressure monitoring'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult mothers who are pregnant with single fetuses over 35 weeks gestational age undergoing planned cesarean delivery under spinal anesthesia\n\nExclusion Criteria:\n\n* Multiple fetal pregnancy\n\n * Preexisting hypertension or pregnancy-induced hypertension\n\n * Underlying heart disease\n\n * Underlying cerebrovascular disease\n\n * Known fetal anomaly\n\n * Contraindicated in spinal anesthesia\n\n * Any sign of onset of labor\n\n * Body weight \\<45 kg or body weight\\> 90 kg\n\n * Height \\<145cm or height\\> 180cm\n\n * All other cases in which researchers determine to be inappropriate for this clinical trial'}, 'identificationModule': {'nctId': 'NCT04752904', 'briefTitle': 'Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Noninvasive Continuous Blood Pressure Monitoring for Preventing Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2010-093-1165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ClearSight group', 'description': 'Non-invasive, continuous blood pressure is monitored using ClearSight Sytem, with a finger cuff around the middle finger, and the anesthesiologist manages blood pressure based on this.', 'interventionNames': ['Device: ClearSight System']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The blood pressure is measured at 1-minute intervals by non-invasive blood pressure monitor using the arm cuff, and the anesthesiologist in charge manages the blood pressure based on the measured blood pressure.'}], 'interventions': [{'name': 'ClearSight System', 'type': 'DEVICE', 'description': 'Non-invasive, continuous blood pressure is monitored using ClearSight Sytem', 'armGroupLabels': ['ClearSight group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sun-Kyung Park, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sun-Kyung Park', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}