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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02142985
Acronym
VOS-HI
Enrollment
88
Registered
2014-05-20
Start date
2014-04-30
Completion date
2015-10-31
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability

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.

Interventions

vascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
central venous oxygen saturation (ScvO2) variationat baseline and after 10 minutesthe ScvO2 is first measured at baseline via a central venous catheter and blood gaz, then after vascular filling (500 ml of colloid solution (Plasmagel) over thirty minutes).

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026