Transthoracic Echocardiography of the Superior Vena Cava in Intensive Care Units (ICU) Intubated Patients (CAVSUP)

Transthoracic Echocardiographic Assessment of the Superior Vena Cava Flow Respiratory Variation in ICU Intubated Patients

Acute circulatory failure is frequent, affecting up to one-third of patients admitted to intensive care units (ICU). Monitoring hemodynamics and cardiac function is therefore a major concern. Analysis of respiratory diameter variations of the superior vena cava (SVC) is easily obtained with transesophageal echocardiography (TEE) and is helpful to assess fluid responsiveness.

Transthoracic echocardiography (TTE) exploration of the SVC is not used in routine. Recently, micro-convex ultrasound transducers have been marketed and these may be of use for non-invasive SVC flow examination. However, analysis of diameter variations of the SVC with TTE does not seem to be possible since the approach from the supraclavicular fossa does not allow for a good visualization of the SVC walls.

It was recently demonstrated in a short pilot study that TTE examination of the SVC flow with a micro-convex ultrasound transducer (GE 8C-RS) seems both easy to learn and to use (feasibility = 84.9%), and is reproducible in most ventilated ICU patients with an intraclass correlation coefficient for the systolic fraction of the superior vena cava flow of 0.90 (95% confidence interval [0.86-0.93]).

The hypothesis is that cardio-respiratory interactions in intubated-ventilated patients are responsible of SVC flow variations and that the analysis of the SVC flow respiratory variations could be a new predictive tool of fluid responsiveness.

Study Overview

• Status: Unknown
• Conditions: Intubated Patients; Admission in Intensive Care Unit
• Intervention / Treatment: Other: Passive leg raising (PLR); Device: Echo-Doppler measurements

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bertrand DEVIGNE, M.D, PhD; Phone Number: +33 04.72.11.08.52; Email: bertrand.devigne@chu-lyon.fr
• Study Contact Backup: Name: Guillaume MARCOTTE, M.D, PhD; Phone Number: +33 04.72.11.63.45; Email: guillaume.marcotte@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69003
    • Recruiting
    • Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot,
    • Contact: Bertrand DEVIGNE, MD, PhD; Phone Number: 0033472110852; Email: bertrand.devigne@chu-lyon.fr
    • Contact: Guillaume MARCOTTE, MD, PhD; Phone Number: 0033472116345; Email: guillaume.marcotte@chu-lyon.fr
    • Principal Investigator: Bertrand DEVIGNE, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (≥ 18 years old)
• Admission in ICU after tracheal intubation or tracheal intubation during the ICU stay
• Volume-controlled ventilation with a tidal volume of 8 mL/kg
• Patient or family agreement for the inclusion

Exclusion Criteria:

• Persistence of spontaneous breathing
• Cardiac arrhythmia
• Severe Acute Respiratory Distress Syndrome, defined as PaO2/FIO2 ratio < 100
• Acute right ventricular failure defined by S'VD < 10 cm or Tricuspid Annular Plane Systolic Excursion (TAPSE) < 10 mm measured with Transthoracic Echocardiography (TTE)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ICU intubated patients; After inclusion, Echo-Doppler measurements are performed with Vivid S6 model (GE Healthcare France, Lyon, France). The left ventricular outflow tract velocity time index (LVOT TVI) will be measured with this device. Then, a passive leg raising (PLR) will be performed and finally LVOT VTI will be measured again after PLR Patients will be classified in two groups according to the hemodynamic response to PLR : Patients are responders if LVOT VTI increases of at least 10% after PLR; patients are non-responders if LVOT VTI does not increase or increase of less than 10% after PLR.

Other: Passive leg raising (PLR); PLR is a test that predicts whether cardiac output will increase with volume expansion. By transferring a volume of around 300 mL of venous blood from the lower body toward the right heart, PLR mimics a fluid challenge. However, no fluid is infused and the hemodynamic effects are rapidly reversible, thereby avoiding the risks of fluid overload. PLR starts from the semi-recumbent and not the supine position. PLR is performed by adjusting the bed and not by manually raising the patient's legs; Device: Echo-Doppler measurements; Echo-Doppler measurements are performed with Vivid S6 model (GE Healthcare France, Lyon, France). All measurements are recorded at the end of expiration. Echo-Doppler measurements are performed in the upper part of the SVC, approximately 1 to 2 cm below the brachiocephalic vein. From this view, pulse Doppler is performed. Pulse Doppler waves obtained in the SVC are used to obtain velocity time integrals (VTI). Expiratory VTI is named VTImax and inspiratory VTI is named VTImin. These values will allow the calculation of Respiratory variations of the superior vena cava flow (ΔSVCf). ΔSVCf is calculated as (VTImax- VTImin )/(1/2(VTImax+ VTImin)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventricular outflow tract velocity time index (LVOT TVI)	Echo-Doppler measurements are performed with Vivid S6 model (GE Healthcare France, Lyon, France). All measurements are recorded at the end of expiration. Echo-Doppler measurements are performed in the upper part of the SVC, approximately 1 to 2 cm below the brachiocephalic vein. From this view, pulse Doppler is performed. Pulse Doppler waves obtained in the SVC are used to obtain velocity time integrals (VTI). Expiratory VTI is named VTImax and inspiratory VTI is named VTImin. These values will allow the calculation of Respiratory variations of the superior vena cava flow (ΔSVCf). ΔSVCf is calculated as(VTImax- VTImin )/(1/2(VTImax+ VTImin))	The day of inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
optimal cut-off value of ΔSVCf to predict fluid-responsiveness	The day of inclusion
proportion of patients in which measurement of ΔSVCf is not possible	The day of inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2018
• Primary Completion (Anticipated): May 25, 2020
• Study Completion (Anticipated): May 25, 2020

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: superior vena cava
• Other Study ID Numbers: 69HCL17_0549

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No