Ultrasound of IJVNCT04618419
IJV Sonogram VS Cardiometry in Fluid Responsiveness In CABG
An observational study of Ultrasound of IJV and Electrical Cardiometry, run by Ahmed Abd El-Rahim Abd El-Hamid Hammad at 1 site in Egypt.
Trial summary
The primary aim of the study is to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using sonogram of the internal jugular vein for assessment of vessel distensibility in relation to stroke volume variation (SVV) measaured by electrical cardiometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound of IJV, Electrical Cardiometry
- What is being tested?
- internal jugular vein distensibility index
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2019to 5 Jan 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Demographic data, hemodynamic parameters as heart rate (HR), and mean arterial blood pressure (MAP),CVP and urine output have been registered. Cardiac data derived from electrical cardiometry including: CO ,cardiac index( CI), stroke volume variation( SVV) and thoracic fluid content were also recorded. IJVDI by sonogram was assessed
Who may be able to join
- Adults (>18 years old) Able to provide advanced informed consent Planned for elective CABG surgery
Who cannot join
- Age < 18 years
- Severely reduced preoperative left ventricular ejection fraction < 40 %
- 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: Internal Jugular Vein Sonogram Versus Electrical Cardiometry For Assessment Of Fluid Responsiveness In Adult Undergoing Coronary Artery Bypass Graft Surgery
The primary aim of the study is to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using sonogram of the internal jugular vein for assessment of vessel distensibility in relation to stroke volume variation (SVV) measaured by electrical cardiometry.
The secondary aim is to evaluate the ability of thoracic fluid content (TFC) measured by electrical cardiometry to be an additive value for the assessment of fluid responsiveness.
Read the detailed description
Fluid management is one of the most important treatments for stabilizing hemodynamics in patients after cardiac surgery.Electrical Cardiometry is a method for the non-invasive determination of stroke volume (SV), cardiac output (CO), stroke volume variation (SVV) and other hemodynamic parameters in adults, children, and neonates based on measurement of thoracic electrical bioimpedance and has been validated against "gold standard" methods such as thermodilution method of deriving CO using a pulmonary artery catheter (PAC).
The IJV is, technically, much more easily accessible for sonographic visualization than the IVC, and measurement of the IJV does not require transesophageal echocardiography (TEE). Internal jugular vein distensibility index (IJVDI) has been studied in several studies but its reliability has not been well confirmed in patients during cardiac surgery.
This is a prospective observational study of adults undergoing coronary artery bypass graft surgery . The primary aim of the study is to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using sonogram of the internal jugular vein for assessment of vessel distensibility in relation to stroke volume variation (SVV) measaured by electrical cardiometry.The secondary aim is to evaluate the ability of thoracic fluid content (TFC) measured by electrical cardiometry to be an additive value for the assessment of fluid responsiveness.
Volume responsiveness will be independently assessed by IJV sonogram and electrical cardiometry in following times
- After induction of anesthesia.
- After transfusing 6 ml / kg of hydroxyethyl starch (HES) 6% before sternotomy.
- After closure of the sternum and transfusion of patient's blood.
- Immediately before transferring the patient to ICU and stabilization of hemodynamic parameters by giving fluids needed to patient.
- Immediately after transferring the patient to ICU and stabilization of hemodynamic parameters by giving fluids needed to patient.
- After 2 hour of ICU admission.
- Before weaning from mechanical ventilation Fluid responsiveness will be assessed by examining SVV with a threshold of the SVV = 12% allow discrimination between Responders and Non-responders
- Conditions
- Ultrasound of IJV, Electrical Cardiometry
- Being tested
- internal jugular vein distensibility index
- Keywords
- CABG surgery, Internal jugular vein, stroke volume variation, TFC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal jugular vein distensibility indexDiagnostic test
It is a prospective observational clinical study to correlate hemodynamic monitoring between Electrical Cardiometry and internal jugular vein distensibility index by sonogram
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid responsiveness after fluid challenge
Correlation between SVV and IJVDI
Measured: 24 hours from the start of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start10 May 2019
- Primary completion25 Dec 2019
- Study completion5 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ultrasound of IJVStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Abd El-Rahim Abd El-Hamid Hammad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Abd El-Rahim Abd El-Hamid Hammad, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618419
- Sponsor's protocol ID
- IJVDI and fluid responsiveness
- Status last verified
- Nov 2020
- First submitted
- 20 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aronson S, Nisbet P, Bunke M. Fluid resuscitation practices in cardiac surgery patients in the USA: a survey of health care providers. Perioper Med (Lond). 2017 Oct 19;6:15. doi: 10.1186/s13741-017-0071-6. eCollection 2017.
PubMed 29075482Ma GG, Hao GW, Yang XM, Zhu DM, Liu L, Liu H, Tu GW, Luo Z. Internal jugular vein variability predicts fluid responsiveness in cardiac surgical patients with mechanical ventilation. Ann Intensive Care. 2018 Jan 16;8(1):6. doi: 10.1186/s13613-017-0347-5.
PubMed 29340792
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Jugular Vein Sonogram Versus Electrical Cardiometry For Assessment Of Fluid Responsiveness In Adult Undergoing Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT04618419
- Acronym / sponsor ID
- IJVDI and fluid responsiveness
- Conditions
- Ultrasound of IJV, Electrical Cardiometry
- Keywords
- CABG surgery, Internal jugular vein, stroke volume variation, TFC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ahmed Abd El-Rahim Abd El-Hamid HammadUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 25 Dec 2019 (actual)
- Study completion
- 5 Jan 2020 (actual)
- First posted
- 6 Nov 2020 (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.
The primary aim of the study is to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using sonogram of the internal jugular vein for assessment of vessel distensibility in relation to stroke volume variation (SVV) measaured by electrical cardiometry.
The secondary aim is to evaluate the ability of thoracic fluid content (TFC) measured by electrical cardiometry to be an additive value for the assessment of fluid responsiveness.
Detailed description
Fluid management is one of the most important treatments for stabilizing hemodynamics in patients after cardiac surgery.Electrical Cardiometry is a method for the non-invasive determination of stroke volume (SV), cardiac output (CO), stroke volume variation (SVV) and other hemodynamic parameters in adults, children, and neonates based on measurement of thoracic electrical bioimpedance and has been validated against "gold standard" methods such as thermodilution method of deriving CO using a pulmonary artery catheter (PAC).
The IJV is, technically, much more easily accessible for sonographic visualization than the IVC, and measurement of the IJV does not require transesophageal echocardiography (TEE). Internal jugular vein distensibility index (IJVDI) has been studied in several studies but its reliability has not been well confirmed in patients during cardiac surgery.
This is a prospective observational study of adults undergoing coronary artery bypass graft surgery . The primary aim of the study is to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using sonogram of the internal jugular vein for assessment of vessel distensibility in relation to stroke volume variation (SVV) measaured by electrical cardiometry.The secondary aim is to evaluate the ability of thoracic fluid content (TFC) measured by electrical cardiometry to be an additive value for the assessment of fluid responsiveness.
Volume responsiveness will be independently assessed by IJV sonogram and electrical cardiometry in following times
- After induction of anesthesia.
- After transfusing 6 ml / kg of hydroxyethyl starch (HES) 6% before sternotomy.
- After closure of the sternum and transfusion of patient's blood.
- Immediately before transferring the patient to ICU and stabilization of hemodynamic parameters by giving fluids needed to patient.
- Immediately after transferring the patient to ICU and stabilization of hemodynamic parameters by giving fluids needed to patient.
- After 2 hour of ICU admission.
- Before weaning from mechanical ventilation Fluid responsiveness will be assessed by examining SVV with a threshold of the SVV = 12% allow discrimination between Responders and Non-responders
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Demographic data, hemodynamic parameters as heart rate (HR), and mean arterial blood pressure (MAP),CVP and urine output have been registered. Cardiac data derived from electrical cardiometry including: CO ,cardiac index( CI), stroke volume variation( SVV) and thoracic fluid content were also recorded. IJVDI by sonogram was assessed
Key inclusion criteria (1 listed)
- Adults (>18 years old) Able to provide advanced informed consent Planned for elective CABG surgery
Key exclusion criteria (8 listed)
- Age < 18 years
- Severely reduced preoperative left ventricular ejection fraction < 40 %
- 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 |
|---|---|---|
| internal jugular vein distensibility indexIt is a prospective observational clinical study to correlate hemodynamic monitoring between Electrical Cardiometry and internal jugular vein distensibility index by sonogram | Diagnostic test | – |
Primary outcome
fluid responsiveness after fluid challenge
Time frame: 24 hours from the start of surgery
Correlation between SVV and IJVDI
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 6 Nov 2020.
- Background: PubMed 29075482Aronson S, Nisbet P, Bunke M. Fluid resuscitation practices in cardiac surgery patients in the USA: a survey of health care providers. Perioper Med (Lond). 2017 Oct 19;6:15. doi: 10.1186/s13741-017-0071-6. eCollection 2017.
- Background: PubMed 29340792Ma GG, Hao GW, Yang XM, Zhu DM, Liu L, Liu H, Tu GW, Luo Z. Internal jugular vein variability predicts fluid responsiveness in cardiac surgical patients with mechanical ventilation. Ann Intensive Care. 2018 Jan 16;8(1):6. doi: 10.1186/s13613-017-0347-5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound of IJV and Electrical Cardiometry, run by Ahmed Abd El-Rahim Abd El-Hamid Hammad 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 6 Nov 2020. 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?
fluid responsiveness after fluid challenge (time frame: 24 hours from the start of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618419, which also lists 2 linked publications.
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 6 Nov 2020.