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
About this trial
This is an interventional prevention trial for Prevention of Hypotension
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).
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
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
Learn more about this trial
Point Of Care Ultrasound For Prediction Of Fluid Responsiveness in Off Pump Coronary Artery Bypass Grafting Surgery
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