Nctid:
NCT06236217
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007022", "term"=>"Hypotension"}], "ancestors"=>[{"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M10072", "name"=>"Hypotension", "asFound"=>"Hypotension", "relevance"=>"HIGH"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>300}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2021-08-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-07-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-31", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-31", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-07-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The incidence of post-spinal hypotension", "timeFrame"=>"Intraoperatively", "description"=>"Incidence of spinal anesthesia-induced hypotension was measured. Post spinal hypotension is defined as a drop in the SBP to less than 80mmHg, or less than 75% of the pre-anesthetic value. Hypotension was treated by IV vasopressor boluses (Ephedrine 5 mg)."}], "secondaryOutcomes"=>[{"measure"=>"The amount of intravenous fluids", "timeFrame"=>"Intraoperatively", "description"=>"The amount of intravenous fluids was assessed."}, {"measure"=>"The amount of vasopressor", "timeFrame"=>"Intraoperatively", "description"=>"The amount of vasopressor was assessed. Post spinal hypotension is defined as a drop in the SBP to less than 80mmHg, or less than 75% of the pre-anesthetic value. Hypotension was treated by IV vasopressor boluses (Ephedrine 5 mg)."}, {"measure"=>"Umbilical cord PH", "timeFrame"=>"Immediately after fetal delivery", "description"=>"Umbilical cord PH was measured with fetal delivery."}, {"measure"=>"Neonatal APGAR score", "timeFrame"=>"5 minutes after fetal delivery", "description"=>"Neonatal APGAR score is a score between 7-10 is normal; a score between 4-6 needs proper reevaluation as the infant does require monitoring for 5 minutes. It was measured at 1, 5 minutes."}, {"measure"=>"Complications", "timeFrame"=>"Intraoperatively", "description"=>"Complications such as bradycardia, pruritis and urine retention were measured"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Spinal Anesthesia", "Hypotension", "Cesarian Section", "Carotid Artery", "Corrected Flow Time", "Cardiometry"]}, "descriptionModule"=>{"briefSummary"=>"This research aimed to evaluate and compare the role of carotid corrected flow time (FTc) and electrical cardiometry (EC) in the prediction and prevention of post-spinal hypotension in elective cesarian section.", "detailedDescription"=>"Spinal anesthesia is the procedure of choice for elective cesarean section (CS) because it avoids the most common side effects related to general anesthesia, such as the risk of aspiration, airway problems and the negative effects of intravenous anesthetic drugs on the fetus.\n\nAccurate prediction of post-spinal hypotension could enhance clinical decision-making, optimize management, and facilitate early intervention. More than thirty predictors were used in the prediction of post-spinal hypotension including demographic data, hemodynamic variables, postural stress testing, peripheral perfusion indices, volume and fluid responsiveness indices, and genetic polymorphism.\n\nThe baseline parameters obtained via the bioreactance-based system may serve as a predictor of post-spinal anesthesia hypotension in parturient."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "genderBased"=>true, "genderDescription"=>"Women elective cesarean section", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged ≥ 18 years.\n* American Society of Anesthesiologists (ASA) physical status II.\n* Gestational age (GA) ≥ 36 weeks.\n* Women planned elective cesarean section under spinal anesthesia.\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study.\n* Gestational age of \\< 36 or ≥40 weeks of pregnancy.\n* Pregnancy-induced hypertension.\n* Diabetes.\n* Cardiovascular diseases, arrhythmia.\n* Antepartum hemorrhage.\n* Body Mass Index (BMI) above 36 kg/m2.\n* Clinical fetal complications."}, "identificationModule"=>{"nctId"=>"NCT06236217", "briefTitle"=>"Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry", "organization"=>{"class"=>"OTHER", "fullName"=>"Tanta University"}, "officialTitle"=>"Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry: Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"34801/07/21"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"Control group", "description"=>"Patients received standard of care with no intervention before spinal anesthesia."}, {"type"=>"EXPERIMENTAL", "label"=>"Carotid Ultrasound group", "description"=>"The carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia.", "interventionNames"=>["Other: Carotid Ultrasound"]}, {"type"=>"EXPERIMENTAL", "label"=>"Electrical cardiometry group", "description"=>"Stroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia.", "interventionNames"=>["Other: Electrical cardiometry"]}], "interventions"=>[{"name"=>"Carotid Ultrasound", "type"=>"OTHER", "description"=>"The carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia.", "armGroupLabels"=>["Carotid Ultrasound group"]}, {"name"=>"Electrical cardiometry", "type"=>"OTHER", "description"=>"Stroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia.", "armGroupLabels"=>["Electrical cardiometry group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"31527", "city"=>"Tanta", "state"=>"El-Gharbia", "country"=>"Egypt", "facility"=>"Tanta University", "geoPoint"=>{"lat"=>30.78847, "lon"=>31.00192}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"After the end of study for one year.", "ipdSharing"=>"YES", "description"=>"The data will be available upon a reasonable request from the corresponding author after the end of study for one year.", "accessCriteria"=>"The data will be available upon a reasonable request from the corresponding author."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tanta University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine", "investigatorFullName"=>"Mostafa Mahmoud Shehab", "investigatorAffiliation"=>"Tanta University"}}}}
