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Point Of Care Ultrasound For Prediction Of Fluid Responsiveness in Off Pump Coronary Artery Bypass Grafting Surgery

Primary Purpose

Prevention of Hypotension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inferior vena cava diameter measurement by ultrasonography
difference between peak velocities of carotid artery by ultrasound
cardiac output be transthoracic echocardiography
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Hypotension

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with accepted cardiac capacity (EF >45%) Patients scheduled for off pump open heart surgeries for coronary artery grafting Exclusion Criteria: age under 18 years, patients with poor cardiac capacity patients suffering any type of arrhythmias preoperative left ventricular dilatation (end-diastolic dimension ≥6 cm) preoperative severe tricuspid valve regurgitation, preoperative right ventricular dysfunction patients with high intrathoracic pressure e.g.chronic obstructive pulmonary disease (COPD).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    responder

    non responder

    Arm Description

    Outcomes

    Primary Outcome Measures

    cardiac output by transthoracic echocardiography
    cardiac output = stroke volume x heart rate
    cardiac outputby transthoracic echocardiography
    cardiac output = stroke volume x heart rate

    Secondary Outcome Measures

    inferior vena cava diameter by ultrasonography
    inferior vena cava diameter by ultrasonography
    carotid peak velocity by ultrasound
    carotid peak velocity by ultrasound
    central venous pressure measurement
    central venous pressure measurement
    mean blood pressure
    mean blood pressure
    heart rate
    heart rate
    usage of ionotropic support (adrenalin, noreadrenalin,dopamine and dubotamine)

    Full Information

    First Posted
    July 16, 2023
    Last Updated
    July 22, 2023
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05968040
    Brief Title
    Point Of Care Ultrasound For Prediction Of Fluid Responsiveness in Off Pump Coronary Artery Bypass Grafting Surgery
    Official Title
    Point Of Care Ultrasound For Prediction Of Fluid Responsiveness in Off Pump Coronary Artery Bypass Grafting Surgery, Comparison Between Carotid Doppler Peak Velocity And IVC Distensibility Index
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To exclude hypovolemia before starting off pump coronary artery grafting surgeries by an efficient and good predictive test. We will assess the sensitivity and specificity of dynamic IVC-derived parameters (dispensability index) in comparison to carotid Doppler peak velocity as predictors of fluid response before skin incision in patients undergoing off Pump cardiac surgery.
    Detailed Description
    Monitoring We will monitor all patients using, invasive blood pressure, pulse oximeter, central venous pressure (CVP), 5 leads Electrocardiogram ECG and capnogram. Anesthetic technique: Anesthesia will be inducted by; lidocaine 1.5 mg/Kg, fentanyl 10 mic/kg, propofol (2 mg/kg) and atracurium (0.5 mg/kg). After good muscle relaxation, intubation will be done smoothly. Mechanical ventilation parameters will be fixed in all patients during the study period. Tidal volume will be adjusted to 10 ml/kg without positive end expiration pressure. End tidal carbon dioxide will be kept around 35-40 centimeter water(cmH2O). Anesthesia will be maintained by Sevoflurane 2% minimal alveolar concentration(MAC), atracurium infusion; 0.05-0.01 mg/kg/min and fentanyl infusion rate; 1 mic/kg/hour. Study measurements: After induction of anesthesia we will perform the measurement of the diameter of the inferior vena cava through standard ultrasonic techniques. The M-mode portable ultrasound 1-5 megahertz (MHz) transthoracic phased-array transducer probe will be positioned longitudinally along the xiphoid process when the patient is supine. The diameter of the inferior vena cava will be measured at 2 cm close to the entrance of the right atrium. Ultrasound images will be taken at the end of inspiration (Dmax) and at the end expiration (Dmin) to calculate the inferior vena cava dispensability index (dIVC), and will be recorded before and after fluid challenge test of 5 ml/kg crystalloid within 15 min. The inferior vena cava (IVC) distensibility index (IVC-DI) will be calculated using the formula: IVC-DI = IVCmax - IVCmin/ IVCmin. The indices will be expressed as a percentage. Carotid ultrasound images will be obtained from the left common carotid artery( CCA) in both short-axis and long-axis views by experienced sonographers. The patient will be in supine position, with the head rotated slightly to the right. A broadband linear array transducer 12-4 MHz and the short-axis view will be used for orientation and identification of the CCA. Next, in the long-axis view, Peak Waveform Doppler signals will be acquired by placing a 0.5 mm calliper at the center of the vessel and parallel to the vessel walls, approximately 2 cm proximal from the carotid bifurcation. Insonation-angles between the ultrasound beam and blood flow will be maintained. difference of peak velocity(ΔVpeak) of CCA = (MaxCDPV-MinCDPV)+(MaxCDPV+MinCDPV)x100 2 cardiac output (CO) will be recorded as baseline measure and after fluid administration. If CO increased more than 15%, it will be considered fluid responder. Increase in cardiac output = (cardiac output after first fluid challenge - cardiac output before)/cardiac output before) X 100. Transthoracic echocardiography(TTE) will be used to measure LTOT and velocity time integral (VTI) x heart rate (HR). CVP, mean arterial pressure, pulse pressure, difference between diameters of IVC during inspiration and expiration (ΔIVC-d) in single respiratory cycle, and difference between velocities of carotid Doppler peak velocity in single respiratory cycle (ΔCDPV) will all be measured as hemodynamic records. The benefits include declining heart rate, normotension, and increase and urine volume, also known as fluid responsiveness

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prevention of Hypotension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    responder
    Arm Type
    Active Comparator
    Arm Title
    non responder
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Inferior vena cava diameter measurement by ultrasonography
    Intervention Description
    The diameter of the inferior vena cava will be measured at 2 cm close to the entrance of the right atrium. Ultrasound images will be taken at the end of inspiration (Dmax) and at the end expiration (Dmin) to calculate the inferior vena cava dispensability index (dIVC), and will be recorded before and after fluid challenge test of 5 ml/kg crystalloid within 15 min. The IVC distensibility index (IVC-DI) will be calculated using the formula: IVC-DI = IVCmax - IVCmin/ IVCmin. The indices will be expressed as a percentage.
    Intervention Type
    Procedure
    Intervention Name(s)
    difference between peak velocities of carotid artery by ultrasound
    Intervention Description
    Carotid ultrasound images will be obtained from the left CCA in both short-axis and long-axis views by experienced sonographers. The patient will be in supine position, with the head rotated slightly to the right. A broadband linear array transducer 12-4 MHz and the short-axis view will be used for orientation and identification of the CCA. Next, in the long-axis view, Peak Waveform Doppler signals will be acquired by placing a 0.5 mm calliper at the center of the vessel and parallel to the vessel walls, approximately 2 cm proximal from the carotid bifurcation. Insonation-angles between the ultrasound beam and blood flow will be maintained. ΔVpeakCCA = (MaxCDPV-MinCDPV)+(MaxCDPV+MinCDPV)x100
    Intervention Type
    Procedure
    Intervention Name(s)
    cardiac output be transthoracic echocardiography
    Intervention Description
    CO will be recorded as baseline measure and after fluid administration. If CO increased more than 15%, it will be considered fluid responder. Increase in cardiac output = (cardiac output after first fluid challenge - cardiac output before)/cardiac output before) X 100. TTE will be used to measure LTOT and VTI x HR.
    Primary Outcome Measure Information:
    Title
    cardiac output by transthoracic echocardiography
    Description
    cardiac output = stroke volume x heart rate
    Time Frame
    immediately before fluid administration
    Title
    cardiac outputby transthoracic echocardiography
    Description
    cardiac output = stroke volume x heart rate
    Time Frame
    immediately after fluid administration
    Secondary Outcome Measure Information:
    Title
    inferior vena cava diameter by ultrasonography
    Time Frame
    immediately before fluid administration
    Title
    inferior vena cava diameter by ultrasonography
    Time Frame
    immediately after fluid administration
    Title
    carotid peak velocity by ultrasound
    Time Frame
    immediately before fluid administration
    Title
    carotid peak velocity by ultrasound
    Time Frame
    immediately after fluid administration
    Title
    central venous pressure measurement
    Time Frame
    immediately before fluid administration
    Title
    central venous pressure measurement
    Time Frame
    immediately after fluid administration
    Title
    mean blood pressure
    Time Frame
    immediately before fluid administration
    Title
    mean blood pressure
    Time Frame
    immediately after fluid administration
    Title
    heart rate
    Time Frame
    immediately before fluid administration
    Title
    heart rate
    Time Frame
    immediately after fluid administration
    Title
    usage of ionotropic support (adrenalin, noreadrenalin,dopamine and dubotamine)
    Time Frame
    during the intraoperative period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with accepted cardiac capacity (EF >45%) Patients scheduled for off pump open heart surgeries for coronary artery grafting Exclusion Criteria: age under 18 years, patients with poor cardiac capacity patients suffering any type of arrhythmias preoperative left ventricular dilatation (end-diastolic dimension ≥6 cm) preoperative severe tricuspid valve regurgitation, preoperative right ventricular dysfunction patients with high intrathoracic pressure e.g.chronic obstructive pulmonary disease (COPD).

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Point Of Care Ultrasound For Prediction Of Fluid Responsiveness in Off Pump Coronary Artery Bypass Grafting Surgery

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