Inferior Vena Cava Compliance in Trans-thoracic Echocardiography: is the Trans-hepatic Window as Reliable as the Subcostal One
NCT ID: NCT04866095
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
53 participants
INTERVENTIONAL
2021-06-25
2021-11-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surgery
All patients, who have given their consent, aged over 18 years, with a sinus rhythm, requiring a surgical procedure that allows obtaining high quality transthoracic echocardiogram imaging without pain and discomfort.
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.
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Examples of such surgeries are:
* Orthopaedic surgery: interventions of upper limbs.
* Stomatology: dental extractions
* Gastroenterology: oesophagus gastroscopy
* Maxillo-facial surgery: septoplasties, rhinoplasties, Le Fort surgeries
* ENT surgery: thyroidectomy, sleep endoscopies
* Gynaecology: hysteroscopy, voluntary terminations of pregnancy
* Ophthalmic surgery
Exclusion Criteria
* suboptimal image acquisition
* atrial fibrillation, patients with 6 or more extra systoles per minute
* cardiac valvular pathologies
* TTE imaging causing pain and/or discomfort to the patient
* surgeries that don't allow obtaining high quality imaging, elevated intra-abdominal pressure.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brugmann University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Denis SCHMARTZ
Head of anesthesiology department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesco Zuccarini
Role: PRINCIPAL_INVESTIGATOR
CHU Brugmann
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Brugmann
Brussels, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUB-WICAVE
Identifier Type: -
Identifier Source: org_study_id