Clinical trial NCT03508401: Transthoracic Echocardiography of the Superior Vena Cava in Intensive Care Units (ICU) Intubated Patients
Official title: Transthoracic Echocardiographic Assessment of the Superior Vena Cava Flow Respiratory Variation in ICU Intubated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubated Patients
Admission in Intensive Care Unit
Keywords: superior vena cava
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: ventricular outflow tract velocity time index (LVOT TVI)
timeFrame: The day of inclusion
Secondary outcomes:
measure: optimal cut-off value of ΔSVCf to predict fluid-responsiveness
timeFrame: The day of inclusion
measure: proportion of patients in which measurement of ΔSVCf is not possible
timeFrame: The day of inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot,
Study officials:
References: