Clinical trial NCT02142985: Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study
Official title: Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemodynamic Instability
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: central venous oxygen saturation (ScvO2) variation
timeFrame: at baseline and after 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency department of university hospital Fattouma Bourguiba of Monastir
Study officials:
affiliation: Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia
name: Nouira Samir, Professor
role: STUDY_DIRECTOR
References:
citation: Khalil MH, Sekma A, Zhani W, Zorgati A, Ben Soltane H, Nouira S; GREAT Network. Variation in central venous oxygen saturation to assess volume responsiveness in hemodynamically unstable patients under mechanical ventilation: a prospective cohort study. Crit Care. 2021 Jul 13;25(1):245. doi: 10.1186/s13054-021-03683-6. No abstract available.