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Inferior Vena Cava Compliance in Trans-thoracic Echocardiography: is the Trans-hepatic Window as Reliable as the Subcostal One

NCT04866095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-11-10

No results posted yet for this study

Summary

The ability to assess intravascular volume is an essential part of perioperative care: insufficient intravascular volume can result in decreased oxygen delivery to tissues and organ dysfunction, while fluid overload can contribute to the development of oedema, organ dysfunction, respiratory failure and healing defect.

At the present state, there are many different methods of interpreting intravascular circulating blood volume. Non-invasive techniques such as the Clear Sight System, and the transthoracic echocardiogram (TTE) have been proposed as non-invasive methods to assess patient' blood volume.

The aim of this study is to assess whether the measure of the inferior vena cava (IVC) in the trans-hepatic window is as reliable as in the subcostal window to determine fluid responsiveness in perioperative patients. In this study, preload increase will be obtained through passive leg raising. Sensibility and specificity of the two echocardiographic approaches to predict fluid responsiveness will be compared while using the subcostal window as the "gold standard". The effect of passive leg elevation on patient's cardiac output response will be assessed with two different non-invasive techniques: the Clear Sight system and the TTE.

Conditions

  • Surgical Procedure, Unspecified

Interventions

DEVICE

Transthoracic echocardiogram

Transthoracic echocardiogram (TTE) is a widely used and validated imaging technique which involves the study of the heart and great vessels through multiple examination windows. In particular, the subcostal window represents the gold standard for evaluating the diameter of the inferior vena cava (IVC) and its compliance, allowing the physician to obtain valuable information on the volume status of patients. Acquiring images in the subcostal window with a transthoracic echocardiogram (TTE) can be, in some cases, difficult or impossible due to the presence of drainages or surgical wounds: in such cases an alternative could be represented by the trans-hepatic window. This has not been validated in the scientific litterature.

DEVICE

Clear Sight system

The Clear Sight System is a non-invasive blood pressure (BP) monitoring system, where the CO is determined analysing the photo-plethysmography curve by a miniaturized pressure cuff and infrared LEDs. Its main advantage is to assess CO continuously in a completely non-invasive way, following its variations and thereby contributing to the detection of hypovolaemia. Other visualized parameters are: the stroke volume (SV), the systemic vascular resistance (SVR) as well as the BP and the heart rate (HR).

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Principal Investigators

  • Francesco Zuccarini · CHU Brugmann

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2021-10-30
Completion
2021-11-09

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04866095 on ClinicalTrials.gov