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

Intubated Patients Clinical Trial

— CAVSUP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03508401
• Other study ID #: 69HCL17_0549
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: May 25, 2020

Study information

• Verified date: May 2018
• Source: Hospices Civils de Lyon
• Contact: Bertrand DEVIGNE, M.D, PhD
• Phone: 04.72.11.08.52
• Email: bertrand.devigne[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: May 25, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Admission in Intensive Care Unit
• Intubated Patients

Intervention

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 (?SVCf). ?SVCf is calculated as (VTImax- VTImin )/(1/2(VTImax+ VTImin)).

Locations

Country	Name	City	State
France	Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot,	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (?SVCf).; ?SVCf is calculated as(VTImax- VTImin )/(1/2(VTImax+ VTImin))	The day of inclusion
Secondary	optimal cut-off value of ?SVCf to predict fluid-responsiveness		The day of inclusion
Secondary	proportion of patients in which measurement of ?SVCf is not possible		The day of inclusion