Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-16 @ 1:05 AM
Study NCT ID:
NCT06490666
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2024-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(∆PI) to Predict Post-spinal Anesthesia Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-02', 'studyFirstSubmitDate': '2024-06-29', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in pulsatility index to predict post spinal anesthesia induced hypotension', 'timeFrame': 'baseline and immediately after spinal anesthesia', 'description': 'to measure PI before and after spinal anesthesia'}], 'secondaryOutcomes': [{'measure': 'change in resistive index to predict post spinal anesthesia induced hypotension', 'timeFrame': 'baseline and immediately after spinal anesthesia', 'description': 'to measure RI before and after spinal anesthesia'}, {'measure': 'change in waveform morphology to predict post spinal hypotension', 'timeFrame': 'before and immediately after spinal anesthesia', 'description': 'change of waveform morphology before and after spinal anesthesia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Anesthesia Hypotension']}, 'referencesModule': {'references': [{'pmid': '12032019', 'type': 'RESULT', 'citation': 'Hartmann B, Junger A, Klasen J, Benson M, Jost A, Banzhaf A, Hempelmann G. The incidence and risk factors for hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg. 2002 Jun;94(6):1521-9, table of contents. doi: 10.1097/00000539-200206000-00027.'}, {'pmid': '30236233', 'type': 'RESULT', 'citation': 'Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.'}, {'pmid': '34034957', 'type': 'RESULT', 'citation': 'Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.'}]}, 'descriptionModule': {'briefSummary': 'we aimed to evaluate the change in femoral artery pulsatility index as a predictor to post-spinal anesthesia hypotension', 'detailedDescription': 'After spinal anesthesia, hypotension is a common effect that occurs in between 15 and 30% of patients therefore it is essential to prevent such effect.\n\nnumber of variables were utilized for estimating post spinal hypotension, such as assessing heart rate variability, perfusion index, inferior vena cava collapsibility index; however, the majority of these indices needs advanced equipment.\n\ninvestigator of current research decided to study the role of ultrasound derived index namely pulsatility index to predict post spinal anesthesia hypotension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patient undergoing spinal anesthesia for infra-umbilical surgeries', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patient undergoing infra-umbilical surgeries.\n\nExclusion Criteria:\n\n* coagulopathy peripheral vascular disease contraindication to spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT06490666', 'briefTitle': '(∆PI) to Predict Post-spinal Anesthesia Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Change in Femoral Artery Pulsatility Index as a Novel Predictor to Post-spinal Hypotension in Adult Patient Undergoing Infraumbilical Surgeries, a Prospective Observational Study', 'orgStudyIdInfo': {'id': '(∆PI) in spinal hypotension'}}, 'armsInterventionsModule': {'interventions': [{'name': 'femoral artery doppler', 'type': 'DEVICE', 'description': 'femoral artery pulse wave doppler to measure both pulsatility and resistive indices'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Mina Adolf Helmy', 'investigatorAffiliation': 'Cairo University'}}}}