Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT03319433
Status:
UNKNOWN
Last Update Posted:
2018-04-11
First Post:
2017-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia in Lower Segment 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': 'D000081282', 'term': 'Perfusion Index'}], 'ancestors': [{'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hypotension', 'timeFrame': '3 months', 'description': 'compare the incidence of hypotension following SAB for LSCS in parturient with or without a high perfusion index.'}], 'secondaryOutcomes': [{'measure': 'Perfusion index', 'timeFrame': '3 months', 'description': 'To compare the perfusion index (PI) at various intervals between the two groups'}, {'measure': 'Side-effects', 'timeFrame': '3 months', 'description': 'To study the profile of side effects between the two groups.'}, {'measure': 'Systolic blood pressure', 'timeFrame': '3 months', 'description': 'To compare the systolic blood pressure (SBP) at various intervals between the two groups.'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '3 months', 'description': 'To compare the diastolic blood pressure (DBP) at various intervals between the two groups.'}, {'measure': 'Mean arterial pressure', 'timeFrame': '3 months', 'description': 'To compare the mean arterial pressure (MAP) at various intervals between the two groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal hypotension', 'perfusion index', 'caesarean section'], 'conditions': ['Spinal', 'Hypotension', 'Perfusion Index']}, 'referencesModule': {'references': [{'pmid': '27213856', 'type': 'RESULT', 'citation': 'Soma-Pillay P, Nelson-Piercy C, Tolppanen H, Mebazaa A. Physiological changes in pregnancy. Cardiovasc J Afr. 2016 Mar-Apr;27(2):89-94. doi: 10.5830/CVJA-2016-021.'}, {'pmid': '28976555', 'type': 'RESULT', 'citation': 'Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2017 Aug 4;8(8):CD002251. doi: 10.1002/14651858.CD002251.pub3.'}, {'pmid': '25610851', 'type': 'RESULT', 'citation': 'Nag DS, Samaddar DP, Chatterjee A, Kumar H, Dembla A. Vasopressors in obstetric anesthesia: A current perspective. World J Clin Cases. 2015 Jan 16;3(1):58-64. doi: 10.12998/wjcc.v3.i1.58.'}, {'pmid': '28890560', 'type': 'RESULT', 'citation': 'Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16.'}]}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia for caesarean section is invariably associated with variable degree of hypotension. Hypotension that occurs may be detrimental to various organ system due to inadequate perfusion. Various methods and agents have been tried in order to address this problem. However, this calamity is far from over.\n\nPerfusion index is one such attempt to address the problem of hypotension by predicting which group of parturient may develop hypotension. This is a type of non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ration of pulsatile versus the non-pulsatile component of the blood flow. During normal physiological changes in pregnancy, there is relative loss of vascular tone which predisposes this group of patient to sudden development of hypotension after the sympathetic block due to spinal anesthesia.\n\nThus, the aim of the study is to use the non-invasive perfusion index data to predict the occurrence of hypotension in a parturient so that helps us to guide fluid and other drug therapy to address the problem of hypotension.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Parturient presenting to Paropakar Maternity and Women's Hospital for elective caesarean section.", 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ASA II physical status.\n2. Planned for elective LSCS\n3. Gestational age \\>36 weeks and \\<41 weeks\n\nExclusion Criteria:\n\n1. Patient's refusal.\n2. Emergency LSCS.\n3. Patient's with contraindications to spinal anesthesia\n4. Patient with BMI \\>40, preeclampsia, placenta praevia.\n5. Patients with comorbidities like cerebrovascular or cardiovascular disease, and gestational diabetes."}, 'identificationModule': {'nctId': 'NCT03319433', 'briefTitle': 'Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia in Lower Segment Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': "Paropakar Maternity and Women's Hospital"}, 'officialTitle': 'Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia in Lower Segment Caesarean Section', 'orgStudyIdInfo': {'id': 'ParopakarMWH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I (Perfusion Index <3.5)', 'description': 'Those parturient with perfusion index \\<3.5 when baseline monitors are attached while the patient is being prepared for surgery.', 'interventionNames': ['Device: Perfusion Index']}, {'label': 'Group II (Perfusion index >3.5)', 'description': 'Those parturient with perfusion index \\>3.5 when baseline monitors are attached while the patient is being prepared for surgery.', 'interventionNames': ['Device: Perfusion Index']}], 'interventions': [{'name': 'Perfusion Index', 'type': 'DEVICE', 'description': 'Use of non-invasive pulse oximeter to determine perfusion index', 'armGroupLabels': ['Group I (Perfusion Index <3.5)', 'Group II (Perfusion index >3.5)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Paropakar Maternity and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Achyut Sharma', 'investigatorAffiliation': "Paropakar Maternity and Women's Hospital"}}}}