Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study
NCT ID: NCT02142985
Last Updated: 2021-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2014-04-30
2015-10-31
Brief Summary
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Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness to fluid filling maneuver in patients with hemodynamic instability.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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crystalloid solution
vascular filling with 500 ml of crystalloid solution within 10 minutes
Sodium Chloride 0.9% Intravenous
vascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes
Interventions
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Sodium Chloride 0.9% Intravenous
vascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes
Eligibility Criteria
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Inclusion Criteria
* hemodynamic instability (hypotension or shock)
Exclusion Criteria
* severe arrythmia
* valvular regurgitation
* pacemaker
* pulmonary oedema
18 Years
80 Years
ALL
No
Sponsors
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University of Monastir
OTHER
Responsible Party
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Pr. Semir Nouira
Professor
Principal Investigators
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Nouira Samir, Professor
Role: STUDY_DIRECTOR
Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia
Locations
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Emergency department of university hospital Fattouma Bourguiba of Monastir
Monastir, , Tunisia
Countries
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References
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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.
Related Links
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official website
Other Identifiers
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ScvO2 Flo-Trac study
Identifier Type: -
Identifier Source: org_study_id
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