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

Sponsor

University of Monastir (Other)

Overall Status

Completed

CT.gov ID

NCT02142985

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability	Drug: Sodium Chloride 0.9% Intravenous	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: crystalloid solution vascular filling with 500 ml of crystalloid solution within 10 minutes	Drug: Sodium Chloride 0.9% Intravenous vascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes

Arm

Intervention/Treatment

Experimental: crystalloid solution

vascular filling with 500 ml of crystalloid solution within 10 minutes

Drug: Sodium Chloride 0.9% Intravenous

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

Outcome Measures

Primary Outcome Measures

central venous oxygen saturation (ScvO2) variation [at baseline and after 10 minutes]
the 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emergency department of university hospital Fattouma Bourguiba of Monastir	Monastir		Tunisia	6000

Sponsors and Collaborators

University of Monastir

Investigators

Study Director: Nouira Samir, Professor, Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

official website

Publications

None provided.

Responsible Party:

Pr. Semir Nouira, Professor, University of Monastir

ClinicalTrials.gov Identifier:

NCT02142985

Other Study ID Numbers:

ScvO2 Flo-Trac study

First Posted:

May 20, 2014

Last Update Posted:

May 5, 2021

Last Verified:

Apr 1, 2021

Study Results

No Results Posted as of May 5, 2021