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

9 novembre 2021 mis à jour par: Denis SCHMARTZ, Brugmann University Hospital

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

53

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Brussels, Belgique, 1020
        • CHU Brugmann

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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 (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.

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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Difference of sensitivity between the trans-hepatic window versus the subcostal window with TTE
Délai: 20 minutes
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
Délai: 20 minutes
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Difference of sensitivity between the trans-hepatic window versus the subcostal window with the Clear Sight system
Délai: 20 minutes
Comparison of the sensitivity and specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response (with the Clear Sight system) to passive leg raising.
20 minutes
Difference of specificity between the trans-hepatic window versus the subcostal window with the Clear Sight system
Délai: 20 minutes
Comparison of the sensitivity and specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response (with the Clear Sight system) to passive leg raising.
20 minutes
Right atrial pressure (RA)- trans-hepatic window
Délai: 20 minutes
Evaluation of the estimation of RA pressure obtained with the trans-hepatic and sub-costal approaches
20 minutes
Right atrial pressure (RA) - subcostal window
Délai: 20 minutes
Evaluation of the estimation of RA pressure obtained with the trans-hepatic and sub-costal approaches
20 minutes
Cardiac output
Délai: 20 minutes
Cardiac output calculated by: CO= sub-Aortic Velocity Time Integral (sAoVTI) × heart rate in beats per minute (bpm) × left ventricular outflow track (LVOT)
20 minutes

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Francesco Zuccarini, CHU Brugmann

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 juin 2021

Achèvement primaire (Réel)

30 octobre 2021

Achèvement de l'étude (Réel)

9 novembre 2021

Dates d'inscription aux études

Première soumission

26 avril 2021

Première soumission répondant aux critères de contrôle qualité

28 avril 2021

Première publication (Réel)

29 avril 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 novembre 2021

Dernière vérification

1 novembre 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • CHUB-WICAVE

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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