Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study (VOS-HI)

University of Monastir

Status and phase: Completed; Phase 2

Conditions: Hemodynamic Instability

Treatments: Drug: Sodium Chloride 0.9% Intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT02142985

ScvO2 Flo-Trac study

Details and patient eligibility

About

Vascular filling is the main treatment of hypovolemia. Hypovolemia diagnosis can be difficult in some situations and need to be confirmed with other investigations.

Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness to fluid filling maneuver in patients with hemodynamic instability.

Full description

Vascular filling represent the milestone of the treatment of hypovolemia. Its main objective is to restore vascular volume and correct perfusion issues preventing the deleterious consequences of prolonged shock.

Hypovolemia diagnosis is easy to made in obvious clinical situations such as hemorrhagic shock, deshydratation..., but there still many diagnostic difficulties regarding latent hypovolemia especially if associated with left ventricular dysfunction.

In this situations, diagnostic of hypovolemia is hard to made and other investigations are needed.

Central venous pressure (CVP) and pulmonary occlusion artery pressure (PAPO) are the mainly used parameters for indicating vascular filling but actually many studies underline their low liability in this situation.

After vascular filling, outcome measurment is needed to evaluate the efficacity of the treatment.

Outcome measurment based on hemodynamic criteria is still insufficient. In fact, tissue hypoxia persists if the cardio - respiratory system did not adapt to the metabolic needs, that's why a pathway based on therapeutic objectives like venous oxymetry is needed.

Theorically, a filling maneuver is beneficial if associated with a ScvO2 amelioration. It reflects the amelioration of cardiac output and predicts the positive responsivness to the filling test.

Enrollment: 88 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged above 18 year old
• hemodynamic instability (hypotension or shock)

Exclusion criteria

• intra cardiac shunt
• severe arrythmia
• valvular regurgitation
• pacemaker
• pulmonary oedema

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

crystalloid solution

Experimental group

Description:

vascular filling with 500 ml of crystalloid solution within 10 minutes

Treatment:

Drug: Sodium Chloride 0.9% Intravenous