Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04866095 |
| Other study ID # |
CHUB-WICAVE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 25, 2021 |
| Est. completion date |
November 9, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Brugmann University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Assessment of the volume status in perioperative patients relies on two important concepts:
euvolemia and fluid responsiveness.
Euvolemia describes a state of adequate circulating blood volume that allows suitable filling
of the cardiac chambers making possible for the heart to produce a cardiac output that meets
the peripheral oxygen demand.
Fluid responsiveness describes the ability of the heart to adapt blood flow in response to
preload increase.
As euvolemia is the ultimate goal of fluid administration then evaluating fluid
responsiveness reflects the process of working toward establishing euvolemia.
At the present state, there are many different methods of interpreting intravascular
circulating blood volume: those related to pressures measurements: the central venous
pressure (CVP), the pulmonary artery occluded pressure (PAOP), and those related to cardiac
output measurements like thermodilution and pulse contour techniques. It is worth noting that
all these are invasive methods that expose patients to a series of possible side effects such
as: pneumothorax, infections, hematomas and vascular lesions. 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.
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: several studies have reported that these
measurements could predict accurately the hemodynamic response of patient to a change in
cardiac preload. However, acquiring images in the subcostal window 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 which, at the best of the
investigator's knowledge, it has never been validated in the literature.
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).
Passive leg raising (PLR) is a test developed to predict patient's hemodynamic response to
increase preload without any fluid administration. Raising the patient from a semi-recumbent
position to a position with the head at 0° and the legs raised to a 45° angle is associated
with about 300 ml of blood volume mobilization from the lower limbs and splanchnic territory
to the central compartment resulting in increased venous return to the heart. This manoeuvre
provokes a preload increase to which patients could respond with (responder) or without
(non-responders) an augmentation of their cardiac output.
The aim of this study is to assess whether the measure of the 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.
