Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-01 @ 7:33 AM
Study NCT ID:
NCT03864692
Status:
COMPLETED
Last Update Posted:
2019-06-18
First Post:
2019-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for C/S
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-15', 'studyFirstSubmitDate': '2019-02-28', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'perioperative', 'description': 'Blood pressure (mmHg) at supine, head-up, head-down and lateral positions will be recorded and compared between the 2 groups.'}], 'primaryOutcomes': [{'measure': 'pleth variability index (PVI)', 'timeFrame': 'perioperative', 'description': 'PVI values (%)at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.'}, {'measure': 'Perfusion index (PI)', 'timeFrame': 'perioperative', 'description': 'PI values (%) at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.'}], 'secondaryOutcomes': [{'measure': 'heart rate', 'timeFrame': 'perioperative', 'description': 'Heart rate (beat per minute) at supine, head-up, head-down and lateral positions will be recorded and compared between the 2 groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications', 'Hypotension', 'Spinal Anesthesia', 'Perfusion Index', 'Pleth Variability Index']}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration.\n\nPerfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone.\n\nPleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness.\n\nThe aim of this study is to investigate whether the PI and PVI values at different patient positions can predict hypotension during caesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Parturients scheduled for elective low segment caesarean section under spinal anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton parturient\n* planned for elective LSCS under spinal anesthesia\n\nExclusion Criteria:\n\n* gestational age \\< 36 weeks\n* emergency cases\n* placenta previa, pre-eclampsia\n* BMI\\>40\n* Reynauld disease\n* patient refusal\n* cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT03864692', 'briefTitle': 'Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for C/S', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for Caesarean Section', 'orgStudyIdInfo': {'id': 'KSU 2018-163'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypotension group', 'description': 'Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure drop below 80 mmHg or have symptoms of hypotension such as dizziness, nausea and vomiting during the procedure.'}, {'label': 'Normotension group', 'description': 'Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure does not drop below 80 mmHg or have any symptoms of hypotension during the procedure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46100', 'city': 'Kahramanmaraş', 'state': 'In the USA Or Canada, Please Select...', 'country': 'Turkey (Türkiye)', 'facility': 'Kahramanmaras Sutcu Imam University', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'MAHMUT ARSLAN', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}