Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness

National Cancer Institute, Egypt

Status: Completed

Conditions: Volume Overload; Tissue Perfusion

Treatments: Device: OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3; Device: Fujifilm Sonosite M-Turbo C Ultrasound system

Study type: Interventional

Funder types: Other

Identifiers

NCT05104528

AP2105-30104

Details and patient eligibility

About

43 patients between 18-60 years presenting with criteria of sepsis (life-threatening organ dysfunction caused by a dysregulated host response to infection, suspected or documented infection and an acute increase ≥2 SOFA [Sequential Organ Failure Assessment] points) will be enrolled in our study. Approval of the ethical committee and informed written consent from first degree relatives will be issued. They will be given a full and detailed explanation of the intended study protocol and will be informed about the potential benefits of the development of a successful technique as well as the potential side-effects.

To compare the efficacy of non-invasive cardiometry and ultrasound (US) guided inferior vena cava (IVC) collapsibility when assessing the response of septic patients to fluid therapy guidelines of The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); in the first six hours of ICU admission .

Full description

One of the newer non-invasive methods used to assess fluid status has been the IVC collapsibility index (IVC CI) - which has shown encouraging results as a guide to fluid therapy. Studies have shown that there is an increase in CVP and decrease in IVC collapsibility with fluid replacement, as well as that both are affected by changes in intrathoracic pressure and right heart dysfunction.

measurement of (IVC CI) is calculated by ultrasound through maximum IVC diameter - minimum IVC diameter divided by minimum diameter then multiplied by 100.

if it is less than 50% means that the patient is volume non- depleted while if it is more than 50% means the reverse.

The other recent non-invasive monitoring tool is electrical cardiometry. Its idea is based on electrical impedance. The variations in impedance are calculated using an algorithm that allows measurement of the CO as well as other key haemodynamic parameters including preload (Thoracic Fluid Index), afterload (systemic vascular resistance, SVR). This has helped provide a sound guide to each individual patient's response to fluid therapy and selection of the proper cardiovascular medications and support.

To compare the efficacy of non-invasive cardiometry and ultrasound (US) guided inferior vena cava (IVC) collapsibility when assessing the response of septic patients to fluid therapy guidelines of The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); in the first six hours of ICU admission .

Enrollment: 43 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA class I and II
• 18yrs ≥ Age ≤ 60yrs
• Fulfilling criteria of sepsis, as per The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

Exclusion criteria

• Lack of consent
• Active bleeding
• Age < 18yrs or > 60yrs
• Anticipated surgery or dialysis in the next 8hrs
• Aortic regurge
• Arrythmias
• Cardiac tamponade
• Chest wall oedema
• Child B and Child C hepatic patients
• Congestive heart failure
• End-stage kidney disease (ESKD) patients with a creatinine clearance (CrCl) <50ml/min
• Massive bilateral pleural effusion
• Mechanical ventilation
• More than 4hrs after meeting criteria of septic shock
• New York Heart Association (NYHA) III and IV cardiac patients
• Severe ARDS (acute respiratory distress syndrome)
• Tense ascites
• Vasopressor infusion (before or after inclusion in the study)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Non-invasive cardiometry

Other group

Description:

OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 A technique for the non-invasive determination of SV, CO, cardiac index, stroke index and HR along with other hemodynamic parameters such as preload (Thoracic Fluid Index), afterload and others. The changes of impedance over time are integrated in a complex algorithm that allows to measure CO and the other above-mentioned parameters.

Treatment:

Device: Fujifilm Sonosite M-Turbo C Ultrasound system

Device: OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3