Prevention of HypotensionNCT05968040
Point Of Care Ultrasound For Prediction Of Fluid Responsiveness in Off Pump Coronary Artery Bypass Grafting Surgery
A study testing Inferior vena cava diameter measurement by ultrasonography, difference between peak velocities of carotid artery by ultrasound and cardiac output be transthoracic echocardiography in people with Prevention of Hypotension, run by Ain Shams University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prevention of Hypotension
- What is being tested?
- Inferior vena cava diameter measurement by ultrasonography, difference between peak velocities of carotid artery by ultrasound and cardiac output be transthoracic echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with accepted cardiac capacity (EF >45%)
- Patients scheduled for off pump open heart surgeries for coronary artery grafting
Who cannot join
- 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).
About this study
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
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.
Read the 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
- Conditions
- Prevention of Hypotension
- Being tested
- Inferior vena cava diameter measurement by ultrasonography, difference between peak velocities of carotid artery by ultrasound, cardiac output be transthoracic echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior vena cava diameter measurement by ultrasonographyProcedure or surgery
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.
difference between peak velocities of carotid artery by ultrasoundProcedure or surgery
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
cardiac output be transthoracic echocardiographyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| responder | Active comparator | Not described Receives: Procedure: Inferior vena cava diameter measurement by ultrasonography; Procedure: difference between peak velocities of carotid artery by ultrasound; Procedure: cardiac output be transthoracic echocardiography |
| non responder | Active comparator | Not described Receives: Procedure: Inferior vena cava diameter measurement by ultrasonography; Procedure: difference between peak velocities of carotid artery by ultrasound; Procedure: cardiac output be transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output by transthoracic echocardiography
cardiac output = stroke volume x heart rate
Measured: immediately before fluid administration
cardiac outputby transthoracic echocardiography
cardiac output = stroke volume x heart rate
Measured: immediately after fluid administration
Secondary outcomes (11)
inferior vena cava diameter by ultrasonography
Measured: immediately before fluid administration
inferior vena cava diameter by ultrasonography
Measured: immediately after fluid administration
carotid peak velocity by ultrasound
Measured: immediately before fluid administration
carotid peak velocity by ultrasound
Measured: immediately after fluid administration
central venous pressure measurement
Measured: immediately before fluid administration
central venous pressure measurement
Measured: immediately after fluid administration
mean blood pressure
Measured: immediately before fluid administration
mean blood pressure
Measured: immediately after fluid administration
heart rate
Measured: immediately before fluid administration
heart rate
Measured: immediately after fluid administration
usage of ionotropic support (adrenalin, noreadrenalin,dopamine and dubotamine)
Measured: during the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of HypotensionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968040
- Sponsor's protocol ID
- ain shams H.
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05968040
- Acronym / sponsor ID
- ain shams H.
- Conditions
- Prevention of Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| responder | Active comparator | Procedure: Inferior vena cava diameter measurement by ultrasonography, Procedure: difference between peak velocities of carotid artery by ultrasound, Procedure: cardiac output be transthoracic echocardiography |
| non responder | Active comparator | Procedure: Inferior vena cava diameter measurement by ultrasonography, Procedure: difference between peak velocities of carotid artery by ultrasound, Procedure: cardiac output be transthoracic echocardiography |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with accepted cardiac capacity (EF >45%)
- Patients scheduled for off pump open heart surgeries for coronary artery grafting
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inferior vena cava diameter measurement by ultrasonographyThe 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. | Procedure or surgery | non responder, responder |
| difference between peak velocities of carotid artery by ultrasoundCarotid 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 | Procedure or surgery | non responder, responder |
| cardiac output be transthoracic echocardiographyCO 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. | Procedure or surgery | non responder, responder |
Primary outcome
cardiac output by transthoracic echocardiography
Time frame: immediately before fluid administration
cardiac output = stroke volume x heart rate
cardiac outputby transthoracic echocardiography
Time frame: immediately after fluid administration
cardiac output = stroke volume x heart rate
11 secondary outcomes
inferior vena cava diameter by ultrasonography
Time frame: immediately before fluid administration
inferior vena cava diameter by ultrasonography
Time frame: immediately after fluid administration
carotid peak velocity by ultrasound
Time frame: immediately before fluid administration
carotid peak velocity by ultrasound
Time frame: immediately after fluid administration
central venous pressure measurement
Time frame: immediately before fluid administration
central venous pressure measurement
Time frame: immediately after fluid administration
mean blood pressure
Time frame: immediately before fluid administration
mean blood pressure
Time frame: immediately after fluid administration
heart rate
Time frame: immediately before fluid administration
heart rate
Time frame: immediately after fluid administration
usage of ionotropic support (adrenalin, noreadrenalin,dopamine and dubotamine)
Time frame: during the intraoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior vena cava diameter measurement by ultrasonography, difference between peak velocities of carotid artery by ultrasound and cardiac output be transthoracic echocardiography in people with Prevention of Hypotension, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac output by transthoracic echocardiography (time frame: immediately before fluid administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.