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Completed

NCT Number: NCT04618419

IJV Sonogram VS Cardiometry in Fluid Responsiveness In CABG

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria university

Alexandria, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

internal jugular vein distensibility index

Diagnostic Test

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

Primary outcomes

  1. fluid responsiveness after fluid challenge

    Time frame: 24 hours from the start of surgery

    Correlation between SVV and IJVDI

Sponsors and collaborators

Lead sponsor

Ahmed Abd El-Rahim Abd El-Hamid Hammad

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 6, 2020
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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