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

Civil Hospices of Lyon

Status: Unknown

Conditions: Admission in Intensive Care Unit; Intubated Patients

Treatments: Other: Passive leg raising (PLR); Device: Echo-Doppler measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT03508401

69HCL17_0549

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

188 participants in 1 patient group

ICU intubated patients

Experimental group

Description:

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.

Treatment:

Device: Echo-Doppler measurements

Other: Passive leg raising (PLR)