Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-28 @ 6:36 PM
Study NCT ID:
NCT06885593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral Vein Collapsibility Index and Post-Spinal Hypotension in Pregnant Women: Impact of Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016683', 'term': 'Supine Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "In this clinical trial, besides the anesthesiologist performing the ultrasonography (USG), the following parties will be masked:\n\nOutcome Assessor(s): The individuals responsible for measuring the post-spinal hypotension outcomes, such as blood pressure and heart rate, will be blinded to the patient's assigned position (supine or left lateral tilt). This ensures that their measurements and assessments are not influenced by the positioning during the ultrasound evaluation.\n\nData Analysts: The data analysts, who will perform the statistical analysis of the study outcomes, will be blinded to the group assignments (supine or left lateral tilt). This is done to avoid bias in interpreting the results related to the position and its effect on post-spinal hypotension.\n\nPatients: The patients themselves will not be aware of the specific position (supine or left lateral tilt) they are assigned to during the ultrasound procedure, as this will be randomized. However, they will be informed of the pro"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All ultrasonography (USG) procedures will be performed by the same anesthesiologist using a Ultrasound device before the start of spinal anesthesia (SA) and after baseline blood pressure and heart rate have been measured. Patients will be placed in supine and left lateral tilt (LLT) positions. After at least 3 minutes in each position, ultrasound of the inferior vena cava (IVC) and femoral vein (FV) will be performed. The oblique probe will be placed below the xiphoid. Anteroposterior diameters and peak velocities of the IVC will be measured 2-3 cm below the IVC-right atrium For standardization purposes, measurements of the right femoral vein will be used in the study. The FV will be visualized with B-mode ultrasound 2-5 cm below the level of the inguinal ligament where the femoral artery is best palpated, without applying any pressure that may affect the FV diameter.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Post-Spinal Hypotension', 'timeFrame': '40 minute', 'description': 'Post-Spinal Hypotension Measured by Systolic and Diastolic Blood Pressure and Heart Rate Changes Following Spinal Anesthesia in Supine and Left Lateral Tilt Positions Systolic Blood Pressure, Diastolic Blood Pressure, and Heart Rate are now presented as separate outcome measures, each with its own unit of measure.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with time of onset of maternal hypotension, symptomatic hypotension, incidence of bradycardia, cumulative ephedrine requirements, patient satisfaction', 'timeFrame': '24 hours', 'description': 'Secondary maternal outcomes recorded from the induction of spinal anesthesia (SA) to delivery include: time of onset of maternal hypotension (time from SA to first hypotension episode); symptomatic hypotension (hypotension with nausea, vomiting, and/or dizziness); severe hypotension (systolic arterial pressure \\[SAP\\] \\<70% of baseline); minimum recorded SAP; cumulative duration of hypotension (total minutes of SAP \\<90 mmHg or diastolic BP \\<60 mmHg); minimum heart rate (HR); incidence of bradycardia (HR \\<50 bpm); atropine use for bradycardia; cumulative ephedrine requirements (total ephedrine dose administered); and patient satisfaction (rated on a Likert scale from 1-5).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Induced Hypotension in Cesarean Delivery']}, 'referencesModule': {'references': [{'pmid': '33472587', 'type': 'BACKGROUND', 'citation': 'Yao SF, Zhao YH, Zheng J, Qian JY, Zhang C, Xu Z, Xu T. The transverse diameter of right common femoral vein by ultrasound in the supine position for predicting post-spinal hypotension during cesarean delivery. BMC Anesthesiol. 2021 Jan 20;21(1):22. doi: 10.1186/s12871-021-01242-8.'}, {'pmid': '37476444', 'type': 'BACKGROUND', 'citation': 'Lal J, Jain M, Rahul, Singh AK, Bansal T, Vashisth S. Efficacy of inferior vena cava collapsibility index and caval aorta index in predicting the incidence of hypotension after spinal anaesthesia- A prospective, blinded, observational study. Indian J Anaesth. 2023 Jun;67(6):523-529. doi: 10.4103/ija.ija_890_22. Epub 2023 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to improve the safety of spinal anesthesia for pregnant patients undergoing elective cesarean delivery. Specifically, the investigators are investigating whether ultrasound measurements of a vein in the groin (the right common femoral vein, or RCFV) can help predict the risk of low blood pressure (hypotension) after spinal anesthesia. The main question it aims to answer is:\n\nCan femoral vena cava collapsibility index predict post-spinal hypotension in pregnant women in left lateral tilt position?\n\nBefore receiving spinal anesthesia, participants will undergo a brief and painless ultrasound examination of the RCFV in the groin area while lying in a specific position."', 'detailedDescription': 'Post-spinal hypotension (PSH) is defined as a systolic arterial blood pressure (SBP) decrease of more than 20% from baseline or an SBP drop below 100 mmHg. This reduction in blood pressure may compromise uteroplacental perfusion, leading to fetal hypoxia and acidosis. PSH is the most common complication in obstetric anesthesia, with an incidence of up to 95% in healthy women. Despite extensive research, the most effective strategy to maintain hemodynamic stability remains under investigation. Various methods, including crystalloid and colloid fluid loading, leg wrapping, head-down tilt, and vasopressor use, have been explored for both treatment and prevention.\n\nThe sympatholytic effect of spinal anesthesia induces vasodilation, exacerbating maternal hypotension due to the gravid uterus compressing the inferior vena cava (IVC). This compression reduces venous return and subsequently decreases the IVC diameter.\n\nCurrent recommendations for term pregnant women undergoing cesarean delivery advocate for a left lateral tilt position to prevent aortocaval compression (ACC), maternal hypotension, and fetal compromise . In the supine position, the IVC is nearly completely obstructed at term up to its bifurcation. However, most women experience only minimal hemodynamic effects due to compensatory mechanisms such as venoconstriction in the lower extremities and collateral circulation via the paraspinal and azygos veins. Clinically significant hemodynamic compromise, known as supine hypotensive syndrome, occurs in approximately 8-10% of term pregnancies, likely due to insufficient compensatory responses .\n\nThe right common femoral vein (RCFV), a continuation of the right external iliac vein, is a tributary of the IVC. Because the RCFV is superficially located, it can be easily visualized using a high-frequency ultrasound probe. Importantly, the RCFV is situated distal to the site of aortocaval compression, making it a potential surrogate marker for hemodynamic changes.\n\nStudy Hypothesis This study hypothesizes that the peak velocity and collapsibility index of the RCFV in the inguinal region, measured in the left lateral 15-degree tilt position, reflect the degree of aortocaval compression. These parameters may help identify pregnant women at high risk of post-spinal hypotension during elective cesarean delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 2\n* Uncomplicated pregnancy\n* Height between 150 cm-180 cm\n* Signed the informed consent form\n* 8 hours of fasting before the operation\n* Patients who refuse normal delivery\n\nExclusion Criteria:\n\n* Obstetric comorbidities affecting caval compression of the aorta\n* Transverse development\n* Fetal macrosomia\n* Uterine anomaly\n* Polyhydramnion\n* Oligohydroamnion\n* Membrane ruptures\n* Intrauterine growth retardation\n* Mothers with hyperactive lung disease\n* Those with autonomic neuropathy\n* Kidney failure\n* Smokers\n* Severe scoliosis or kyphosis\n* Multiple pregnancy (twins, triplets,...)\n* Those who do not reach T6 sensory block level after 10 minutes\n* Those undergoing general anesthesia or IV analgesics for any reason'}, 'identificationModule': {'nctId': 'NCT06885593', 'briefTitle': 'Femoral Vein Collapsibility Index and Post-Spinal Hypotension in Pregnant Women: Impact of Position', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': '"Can Femoral Vena Cava Collapsibility Index Predict Post-spinal Hypotension in Pregnant Women in Left Lateral Tilt Position?"', 'orgStudyIdInfo': {'id': '2025/7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Supine Position', 'description': 'All ultrasonography (USG) procedures will be performed by the same anesthesiologist using a Ultrasound device before the start of spinal anesthesia (SA) and after baseline blood pressure and heart rate have been measured. Patients will be placed in supine position. After at least 3 minutes in each position, ultrasound of the inferior vena cava (IVC) and femoral vein (FV) will be performed. The oblique probe will be placed below the xiphoid. Anteroposterior diameters and peak velocities of the IVC will be measured 2-3 cm below the IVC-right atrium For standardization purposes, measurements of the right femoral vein will be used in the study. The FV will be visualized with B-mode ultrasound 2-5 cm below the level of the inguinal ligament where the femoral artery is best palpated, without applying any pressure that may affect the FV diameter.', 'interventionNames': ['Diagnostic Test: Supine Position', 'Diagnostic Test: Left Lateral Tilt Position']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Left Lateral Tilt Position', 'description': 'All ultrasonography (USG) procedures will be performed by the same anesthesiologist using a Ultrasound device before the start of spinal anesthesia (SA) and after baseline blood pressure and heart rate have been measured.\n\nPatients will be placed in left lateral tilt (LLT) positions. After at least 3 minutes in each position, ultrasound of the inferior vena cava (IVC) and femoral vein (FV) will be performed. The oblique probe will be placed below the xiphoid. Anteroposterior diameters and peak velocities of the IVC will be measured 2-3 cm below the IVC-right atrium For standardization purposes, measurements of the right femoral vein will be used in the study. The FV will be visualized with B-mode ultrasound 2-5 cm below the level of the inguinal ligament where the femoral artery is best palpated, without applying any pressure that may affect the FV diameter.', 'interventionNames': ['Diagnostic Test: Supine Position', 'Diagnostic Test: Left Lateral Tilt Position']}], 'interventions': [{'name': 'Supine Position', 'type': 'DIAGNOSTIC_TEST', 'description': 'All ultrasonography (USG) procedures will be performed by the same anesthesiologist using a Ultrasound device before the start of spinal anesthesia (SA) and after baseline blood pressure and heart rate have been measured. Patients will be placed in supine and left lateral tilt (LLT) positions. After at least 3 minutes in each position, ultrasound of the inferior vena cava (IVC) and femoral vein (FV) will be performed. The oblique probe will be placed below the xiphoid. Anteroposterior diameters and peak velocities of the IVC will be measured 2-3 cm below the IVC-right atrium For standardization purposes, measurements of the right femoral vein will be used in the study. The FV will be visualized with B-mode ultrasound 2-5 cm below the level of the inguinal ligament where the femoral artery is best palpated, without applying any pressure that may affect the FV diameter.', 'armGroupLabels': ['Left Lateral Tilt Position', 'Supine Position']}, {'name': 'Supine Position', 'type': 'DIAGNOSTIC_TEST', 'description': 'All ultrasonography (USG) procedures will be performed by the same anesthesiologist using a Ultrasound device before the start of spinal anesthesia (SA) and after baseline blood pressure and heart rate have been measured. Patients will be placed in supine position. After at least 3 minutes in each position, ultrasound of the inferior vena cava (IVC) and femoral vein (FV) will be performed. The oblique probe will be placed below the xiphoid. Anteroposterior diameters and peak velocities of the IVC will be measured 2-3 cm below the IVC-right atrium For standardization purposes, measurements of the right femoral vein will be used in the study. The FV will be visualized with B-mode ultrasound 2-5 cm below the level of the inguinal ligament where the femoral artery is best palpated, without applying any pressure that may affect the FV diameter.', 'armGroupLabels': ['Left Lateral Tilt Position', 'Supine Position']}, {'name': 'Left Lateral Tilt Position', 'type': 'DIAGNOSTIC_TEST', 'description': 'All ultrasonography (USG) procedures will be performed by the same anesthesiologist using a Ultrasound device before the start of spinal anesthesia (SA) and after baseline blood pressure and heart rate have been measured. Patients will be placed in left lateral tilt (LLT) position. After at least 3 minutes in each position, ultrasound of the inferior vena cava (IVC) and femoral vein (FV) will be performed. The oblique probe will be placed below the xiphoid. Anteroposterior diameters and peak velocities of the IVC will be measured 2-3 cm below the IVC-right atrium For standardization purposes, measurements of the right femoral vein will be used in the study. The FV will be visualized with B-mode ultrasound 2-5 cm below the level of the inguinal ligament where the femoral artery is best palpated, without applying any pressure that may affect the FV diameter.', 'armGroupLabels': ['Left Lateral Tilt Position', 'Supine Position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34844', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kazım Karaaslan Head of Department, Medical Doctor, Professor', 'role': 'CONTACT', 'email': 'kkaraaslan@bezmialem.edu.tr', 'phone': '+905055213865'}, {'name': 'Mehmet SARI, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bezmialem Vakıf Univeristesi Dragos Hastanesi Yalı, Kennedy Cd. No:16.', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'MEHMET SARI Dr, Medical Doctor', 'role': 'CONTACT', 'email': 'mehmet.sari@bezmialem.edu.tr', 'phone': '+095454624611'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mehmet Sarı', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mehmet Sarı', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}