IJV Sonogram VS Cardiometry in Fluid Responsiveness In CABG

Electrical Cardiometry Clinical Trial

Official title:

Internal Jugular Vein Sonogram Versus Electrical Cardiometry For Assessment Of Fluid Responsiveness In Adult Undergoing Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618419
• Other study ID #: IJVDI and fluid responsiveness
• Status: Completed
• Start date: May 10, 2019
• Est. completion date: January 5, 2020

Study information

• Verified date: November 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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

1. After induction of anesthesia.

2. After transfusing 6 ml / kg of hydroxyethyl starch (HES) 6% before sternotomy.

3. After closure of the sternum and transfusion of patient's blood.

4. Immediately before transferring the patient to ICU and stabilization of hemodynamic parameters by giving fluids needed to patient.

5. Immediately after transferring the patient to ICU and stabilization of hemodynamic parameters by giving fluids needed to patient.

6. After 2 hour of ICU admission.

7. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 5, 2020
• Est. primary completion date: December 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adults (>18 years old) Able to provide advanced informed consent Planned for elective CABG surgery

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Electrical Cardiometry
• Ultrasound of IJV

Intervention

Diagnostic Test:
• internal jugular vein distensibility index
It is a prospective observational clinical study to correlate hemodynamic monitoring between Electrical Cardiometry and internal jugular vein distensibility index by sonogram

Locations

Country	Name	City	State
Egypt	Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Abd El-Rahim Abd El-Hamid Hammad

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

Ma 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid responsiveness after fluid challenge	Correlation between SVV and IJVDI	24 hours from the start of surgery