Coronary Bypass StenosisNCT05945303
Correlation Between Internal Jugular Vein Ultrasound and Electrical Cardiometry
A study testing Coronary Artery Bypass Grafting surgery in people with Coronary Bypass Stenosis and Coronary Artery Bypass Grafting Surgery, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Coronary artery bypass graft (CABG) surgery is one of the most frequently performed cardiac surgery procedures worldwide. CABG has been used for more than 40 years to relieve symptoms and to reduce the risk of death in patients with ischemic heart disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Coronary Bypass Stenosis, Coronary Artery Bypass Grafting Surgery
- What is being tested?
- Coronary Artery Bypass Grafting surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 30 Aug 2023
- 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
- Adult patients (above 18 years old to be able to provide advanced informed consent Planned for elective CABG surgery) both male and female will be included in the study
Who cannot join
- Severely reduced preoperative left ventricular ejection fraction (< 40 %).
- Patients who will develop any complication after fluid infusion as pulmonary edema and heart failure will be excluded from the study.
- Significant cardiac arrhythmia.
- Significant valvular heart disease.
- Clinically evident pulmonary disease.
- Bilaterally inserted venous catheters (jugular or subclavian vein).
- History of radiotherapy or surgery of the neck region.
- Inability to obtain interpretable ultrasound images due to a difficult acoustic window.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Internal Jugular Vein Ultrasound and Electrical Cardiometry in Assessment of Fluid Responsiveness in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Coronary artery bypass graft (CABG) surgery is one of the most frequently performed cardiac surgery procedures worldwide. CABG has been used for more than 40 years to relieve symptoms and to reduce the risk of death in patients with ischemic heart disease.
Read the detailed description
Cardiopulmonary bypass can produce changes in fluid physiology and fluid responsiveness in patients characterized by increased interstitial fluid as a consequence of decreased cardiac output and inflammatory changes. This shift of fluid from intravascular space to the intrtstitial space, in addition to blood and fluid losses during the surgical procedure can result in an intravascular hypovolemia that requires fluid resuscitation.
Fluid management is one of the most important treatments for stabilizing hemodynamics in patients during and after cardiac surgery. Hypovolemia may leads to inadequate organ perfusion, whereas fluid overload may lead to postoperative complications such as congestive heart failure or pulmonary edema, In addition to patients who underwent cardiac surgery have a certain degree of myocardial stunning and hence cautions should be taken regarding fluid management in patients with limited cardiac reserve.
Fluid responsiveness (FR) is generally defined as an increase of 10-15% in stroke volume (SV), cardiac output (CO), or cardiac index (CI) in response to volume expansion and indicates unmasked hypovolemia or preload dependacy.
The methods for assessing fluid responsiveness have been evolved from static and volume parameters such as central venous pressure (CVP), pulmonary artery occlusion pressure (PAOP), inferior vena cava (IVC) and superior vena cava (SVC) diameters, right ventricular end-diastolic volume and right ventricular end-diastolic volume, which are unable to predict fluid responsiveness to dynamic indices such as pulse pressure variation (PPV),stroke volume variation (SVV), Pleth variability index (PVI) and aortic blood flow which is based on heart-lung interactions during mechanical ventilation, which have amodest degree of accuracy.
Techniques based on either a virtual or real fluid challenge such as passive led raising (PLR) and rapid fluid challenge (100-250cc) have a high degree of accuracy in predicting fluid responsiveness.
Over the last decade, a number of studies have used heart-lung interactions during mechanical ventilation to assess fluid responsiveness; specifically pulse pressuer variation (PPV) derived from analysis of the arterial blood pressure wave form, stroke volume variation (SVV) derived from pulse-contour analysis (measured by lithium dilution cardiac output monitoring system (LiDDCO) or pulse index continuous cardiac output monitoring system (PiCCO), and the variation of the amplitude of the pulse oximter plethysmographic waveform have been shown to be highly predictive of fluid responsiveness.
However, dynamic parameters are unreliable during spontaneous breathing activity. To overcome the limited accuracy of these hemodynamic parameters in this specific clinical scenario, a passive leg raising (PLR) manoeuver has been suggested to be reliable predictor of fluid responsiveness during spontaneous breathing.
SVV can be monitored with the PiCCO system requiring transpulmonary thermodilution,It is an invasive procedure requires the venous access and balloon flotation of the catheter through the right side.
Accordingly, there are complications associated with detection with this system, and some are even fatal. Furthermore, this system requires an elaborate protocol for intermittent injections into pulmonary artery catheter thermodilution.
- Being tested
- Coronary Artery Bypass Grafting surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Bypass Grafting surgeryProcedure or surgery
Assessing the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using ultrasonography of the internal jugular vein for assessment of vessel distensibilty in relation to stroke volume variation (SVV) measured by electrical cardiometry.
| Study group | Role | What they receive |
|---|---|---|
| Responder group | Experimental | About 20 Adult patients Planned for elective CABG surgery Receives: Procedure: Coronary Artery Bypass Grafting surgery |
| Not Responder group | Experimental | About 20 Adult patients Planned for elective CABG surgery Receives: Procedure: Coronary Artery Bypass Grafting surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of predicting fluid responsiveness
to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using ultrasonography of the internal jugular vein for assessment of vessel distensibilty in relation to stroke volume variation (SVV) measured by electrical cardiometry.
Measured: 2 hours after the coronary artery bypass graft surgery
Secondary outcomes (1)
Thoracic fluid content
Evaluate the ability of thoracic fluid content (TFC) measured by electrical cardiometry to be an additive for the assessment of fluid responsiveness.
Measured: 2 hours after the coronary artery bypass graft surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Mar 2023
- Primary completion1 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bypass StenosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mofeed Abdallah, Professor, Study chair, Al-Azhar University, Faculty of medicine for boysMohamed Abdelgawad, Assist.Professor, Study director, Department of Anesthesia,Faculty of Medicine,Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945303
- Sponsor's protocol ID
- Anas Ezzat Fathy
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Internal Jugular Vein Ultrasound and Electrical Cardiometry in Assessment of Fluid Responsiveness in Patients Undergoing Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT05945303
- Acronym / sponsor ID
- Anas Ezzat Fathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 14 Jul 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.
Coronary artery bypass graft (CABG) surgery is one of the most frequently performed cardiac surgery procedures worldwide. CABG has been used for more than 40 years to relieve symptoms and to reduce the risk of death in patients with ischemic heart disease.
Detailed description
Cardiopulmonary bypass can produce changes in fluid physiology and fluid responsiveness in patients characterized by increased interstitial fluid as a consequence of decreased cardiac output and inflammatory changes. This shift of fluid from intravascular space to the intrtstitial space, in addition to blood and fluid losses during the surgical procedure can result in an intravascular hypovolemia that requires fluid resuscitation.
Fluid management is one of the most important treatments for stabilizing hemodynamics in patients during and after cardiac surgery. Hypovolemia may leads to inadequate organ perfusion, whereas fluid overload may lead to postoperative complications such as congestive heart failure or pulmonary edema, In addition to patients who underwent cardiac surgery have a certain degree of myocardial stunning and hence cautions should be taken regarding fluid management in patients with limited cardiac reserve.
Fluid responsiveness (FR) is generally defined as an increase of 10-15% in stroke volume (SV), cardiac output (CO), or cardiac index (CI) in response to volume expansion and indicates unmasked hypovolemia or preload dependacy.
The methods for assessing fluid responsiveness have been evolved from static and volume parameters such as central venous pressure (CVP), pulmonary artery occlusion pressure (PAOP), inferior vena cava (IVC) and superior vena cava (SVC) diameters, right ventricular end-diastolic volume and right ventricular end-diastolic volume, which are unable to predict fluid responsiveness to dynamic indices such as pulse pressure variation (PPV),stroke volume variation (SVV), Pleth variability index (PVI) and aortic blood flow which is based on heart-lung interactions during mechanical ventilation, which have amodest degree of accuracy.
Techniques based on either a virtual or real fluid challenge such as passive led raising (PLR) and rapid fluid challenge (100-250cc) have a high degree of accuracy in predicting fluid responsiveness.
Over the last decade, a number of studies have used heart-lung interactions during mechanical ventilation to assess fluid responsiveness; specifically pulse pressuer variation (PPV) derived from analysis of the arterial blood pressure wave form, stroke volume variation (SVV) derived from pulse-contour analysis (measured by lithium dilution cardiac output monitoring system (LiDDCO) or pulse index continuous cardiac output monitoring system (PiCCO), and the variation of the amplitude of the pulse oximter plethysmographic waveform have been shown to be highly predictive of fluid responsiveness.
However, dynamic parameters are unreliable during spontaneous breathing activity. To overcome the limited accuracy of these hemodynamic parameters in this specific clinical scenario, a passive leg raising (PLR) manoeuver has been suggested to be reliable predictor of fluid responsiveness during spontaneous breathing.
SVV can be monitored with the PiCCO system requiring transpulmonary thermodilution,It is an invasive procedure requires the venous access and balloon flotation of the catheter through the right side.
Accordingly, there are complications associated with detection with this system, and some are even fatal. Furthermore, this system requires an elaborate protocol for intermittent injections into pulmonary artery catheter thermodilution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responder group | Experimental | Procedure: Coronary Artery Bypass Grafting surgeryAbout 20 Adult patients Planned for elective CABG surgery |
| Not Responder group | Experimental | Procedure: Coronary Artery Bypass Grafting surgeryAbout 20 Adult patients Planned for elective CABG surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients (above 18 years old to be able to provide advanced informed consent Planned for elective CABG surgery) both male and female will be included in the study
Key exclusion criteria (8 listed)
- Severely reduced preoperative left ventricular ejection fraction (< 40 %).
- Patients who will develop any complication after fluid infusion as pulmonary edema and heart failure will be excluded from the study.
- Significant cardiac arrhythmia.
- Significant valvular heart disease.
- Clinically evident pulmonary disease.
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 |
|---|---|---|
| Coronary Artery Bypass Grafting surgeryAssessing the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using ultrasonography of the internal jugular vein for assessment of vessel distensibilty in relation to stroke volume variation (SVV) measured by electrical cardiometry. | Procedure or surgery | Not Responder group, Responder group |
Primary outcome
Reliability of predicting fluid responsiveness
Time frame: 2 hours after the coronary artery bypass graft surgery
to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using ultrasonography of the internal jugular vein for assessment of vessel distensibilty in relation to stroke volume variation (SVV) measured by electrical cardiometry.
1 secondary outcome
Thoracic fluid content
Time frame: 2 hours after the coronary artery bypass graft surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
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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.
Mofeed Abdallah, Professor study chair
Al-Azhar University, Faculty of medicine for boys
Mohamed Abdelgawad, Assist.Professor study director
Department of Anesthesia,Faculty of Medicine,Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Artery Bypass Grafting surgery in people with Coronary Bypass Stenosis and Coronary Artery Bypass Grafting Surgery, run by Egymedicalpedia at 1 site in Egypt.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reliability of predicting fluid responsiveness (time frame: 2 hours after the coronary artery bypass graft surgery). 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 17 Oct 2023.