Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:18 AM
Study NCT ID:
NCT07370103
Status:
RECRUITING
Last Update Posted:
2026-02-02
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotid Artery Corrected Flow Time and Respiratory Variation of Blood Flow Peak Velocity for Prediction of Hypotension After Induction of General Anaesthesia in Adult Patients With Chronic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prediction of hypotension', 'timeFrame': '3 months', 'description': 'Prediction of hypotension after induction of anesthesia by receiver operating characteristic curves of the carotid artery FTc and ΔVpeak Logistic regression analysis Cutoff value for liver disease patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carotid time,respiratory variation,hypotension,chronic liver disease'], 'conditions': ['Hypotension on Induction']}, 'descriptionModule': {'briefSummary': 'Baseline Measurements\n\nFor the ultrasound parameters, it is the average of three readings In supine position .\n\nThe investigators will continuously monitoring during induction and 10 minutes after.\n\nHemodynamic Monitoring:\n\n* Heart rate from ECG\n* SpO2\n* Etco2\n* Blood pressure . invasive Blood pressure\n* The radial artery level is the site of continuous arterial pressure monitoring with an arterial catheter.\n* Ultrasound Measurements:\n\nThe patient will be positioned in a supine position, with the right side of the neck completely exposed. The transverse part Of the main carotid artery beneath the thyroid cartilage will be precisely identified using ultrasound device (sonosite edge portablp.fojy usa)via a linear array probe (4-15 MHz), with the marker directed toward the patient\'s head. Thus, the sampling line will be positioned at the center of the carotid lumen, around 2 cm from the carotid bifurcation, and the electronic angle correction cursor will be pointed in the direction of blood flow. Insonation angles between the ultrasound beam and blood flow will be maintained at or \\< 60°. Next, the carotid blood flow waveform will be acquired, and the consecutive stable carotid pulse Doppler flow spectrum will be determined with an optimal level of image quality.\n\nThe Correction: To get the corrected carotid flow time (ccFT), the measured FT will be adjusted for the patient\'s heart rate (HR). A commonly used formula is Wodey\'s formula.\n\nA single, experienced sonographer will perform all measurements, and a subset of measurements will be reviewed by a second blinded observer to assess inter-rater reliability."\n\nPeak Velocity: Measure the peak systolic blood flow velocity at the same location.\n\nRespiratory Variation (ΔVpeak): Calculate the difference between the maximum and minimum peak velocities during a single respiratory cycle: \\\\Delta V\\_{peak} = (V\\_{peak(max)} - V\\_{peak(min)}) / ((V\\_{peak(max)} + V\\_{peak(min)})/2) \\\\times 100\\\\%. The patient should be asked to breathe normally during this measurement.\n\nFlow time (FT), which is known as the time period between the systolic increase phase and dicrotic notch, was calculated and then adjusted for heart rate (HR) via equations outlined below.\n\nWodey\'s (W) equation∶ FTc(W) = FT + 1.29 ∗ (HR - 60)\n\nAnasthesia:\n\nPatients will have routine fasting for at least 6 to 8 h and will not allowed to drink any solution or fluid 2 to 4 h prior to surgery.\n\nNo premedication will be given A standardized induction protocol will be used. At the operating theatre, a three-lead electrocardiogram (ECG), pulse oximetry (SpO2), and noninvasive arterial pressure monitoring will be applied.\n\nAfter pre-oxygenation for 5 min anesthesia induction of propofol 1\\_2mg , fentanyl 1 ug/kg, and 0.15 mg/kg cisatracurium . After 3 min of mask ventilation, direct laryngoscopy will be employed for tracheal intubation. . Respiratory setting of anesthesia machine (Aestiva, GE/Datex-Ohmeda) will be set as follows: volume-controlled ventilation (VCV), inspiratory-expiratory (I:E) ratio of 1:2, respiratory rate of 8-10 bpm, tidal volume of 8 mL/kg of ideal weight \\[45.5 + 0.91x (height in cm-152.4)\\], and PEEP of 5 cm H2O in 50% oxygen with air. Respiratory settings will be adjusted to maintain the PETCO2 at less than 50 mmHg. Anesthesia will be maintained with sevoflurane (1.5-2.5%) and intermittent injection of cisatracurium 0.02mg/kg as needed to keep the entropy scale between 40 and 60 and for muscle relaxation. The mean arterial pressure was kept between 60 and 80 mmHg.\n\nHemodynamic Data Collection: Invasive mean arterial pressure (MAP) will be continuously recorded for 5-10 minutes post-induction.\n\nHypotension Definition: Hypotension will be defined as a decrease in MAP by \\>20% from the baseline value or an absolute MAP of \\<65 mmHg for more than one minute.This definition is clinically relevant and widely used in the anesthesia literature.\n\nPostinduction hypotension will be treated with 250 ml saline iv boluse repeated if successfully restore blood pressure.\n\nIf refractory to fluid we will inject intravenous ephedrine in 3 mg bolus doses and repeated when necessary.\n\nSignificant bradycardia (heart rate \\< 40 beats/min) will be treated with intravenous boluses of atropine (0.5 mg).\n\nStudy duration 3 months or end of recruitment of sample'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Adult patients (≥ 18 years) with a confirmed diagnosis of CLD (e.g., cirrhosis, non-alcoholic steatohepatitis)\n* scheduled for elective surgery under general anesthesia.\n* ASA 2,3,4\n* ASA 4 patients will be included only if their baseline MAP is \\>65 mmHg, as per the exclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Adult patients (≥ 18 years) with a confirmed diagnosis of CLD (e.g., cirrhosis, non-alcoholic steatohepatitis)\n\n * scheduled for elective surgery under general anesthesia.\n * ASA 2,3,4\n * ASA 4 patients will be included only if their baseline MAP is \\>65 mmHg, as per the exclusion criteria\n\nExclusion Criteria:\n\n* • Refusal to participate\n\n * Patients with known cardiac disease (e.g., severe valvular disease, congestive heart failure),\n * pre-existing severe hypotension (e.g., mean arterial pressure \\<65 mmHg\n * emergency surgery\n * anatomical variations preventing adequate ultrasound visualization of the carotid artery.\n * Carotid artery stenosis.\n * Mean arterial pressure (MAP) \\> 120 mmHg before anesthesia\n * any previous record of neck surgery or trauma.\n * acute renal injury.\n * oral angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (ACEI)\n * lateral, prone, and lithotomy operations\n * body mass index (BMI) \\> 30 kg/m2 or \\< 15 kg/m2'}, 'identificationModule': {'nctId': 'NCT07370103', 'briefTitle': 'Carotid Artery Corrected Flow Time and Respiratory Variation of Blood Flow Peak Velocity for Prediction of Hypotension After Induction of General Anaesthesia in Adult Patients With Chronic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Carotid Artery Corrected Flow Time and Respiratory Variation of Blood Flow Peak Velocity for Prediction of Hypotension After Induction of General Anaesthesia in Adult Patients With Chronic Liver Disease', 'orgStudyIdInfo': {'id': 'FMASU R331/2025'}, 'secondaryIdInfos': [{'id': 'ain shams university', 'type': 'REGISTRY', 'domain': 'ain shams university'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients presented with hypotension after induction of general anaesthesia', 'description': 'POST INDUCTION HYPOTENSION (PIH ) group'}, {'label': 'patients not presented by hypotension after induction of general anaesthesia', 'description': 'NON POST INDUCTION HYPOTENSION (NON PIH GROUP)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Ainshams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'ismail mohammed mahmoud, assistant professor', 'role': 'CONTACT', 'email': 'doc_ismail_2006@yahoo.com', 'phone': '00201013972871'}, {'name': 'tamer samir abdelsalam, assisstant professor', 'role': 'CONTACT', 'email': 'drtasamir@hotmail.com', 'phone': '002', 'phoneExt': '00201154601505'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant proffesor of anaesthesia', 'investigatorFullName': 'Ismail Mohammed', 'investigatorAffiliation': 'Ain Shams University'}}}}