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

NCT04866095 | Completed

• 1 other identifier: CHUB-WICAVE
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Difference of sensitivity between the trans-hepatic window versus the subcostal window with TTE

  Comparison of the sensitivity of both the trans-hepatic window and the subcostal window to predict the cardiac output response by transthoracic echocardiogram (TTE) to passive leg raising.

  20 minutes

• Difference of specificity between the trans-hepatic window versus the subcostal window with TTE

  Comparison of the specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response by transthoracic echocardiogram (TTE) to passive leg raising.

  20 minutes

Secondary Outcomes (5)

• Difference of sensitivity between the trans-hepatic window versus the subcostal window with the Clear Sight system

  20 minutes

• Difference of specificity between the trans-hepatic window versus the subcostal window with the Clear Sight system

  20 minutes

• Right atrial pressure (RA)- trans-hepatic window

  20 minutes

• Right atrial pressure (RA) - subcostal window

  20 minutes

• Cardiac output

  20 minutes

Study Arms (1)

Surgery

EXPERIMENTAL

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.

Device: Transthoracic echocardiogram; Device: Clear Sight system

Interventions

Transthoracic echocardiogram DEVICE

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.

Surgery

Clear Sight system DEVICE

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).

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients of the CHU Brugmann hospital, who have given their consent, aged over 18 years, with a sinus rhythm, requiring a surgical procedure that allows obtaining high quality TTE imaging without pain and discomfort.
• 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

You may not qualify if:

• Refusal to participate to the study
• 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.

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Francesco Zuccarini

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of anesthesiology department

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: June 25, 2021
• Primary Completion: October 30, 2021
• Study Completion: November 9, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)