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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
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The purpose of this study is to evaluate the stroke volume variation measured by both methods: transpulmonary thermodilution and electrical impedance tomography (EIT), during fluid responsiveness maneuvers and after fluid replacement in the immediate postoperative of coronary artery bypass grafting (CABG) patients. Patients will be hemodinamically monitored with the VolumeView set in combination with EV1000 clinical platform and the display of valuable volumetric parameters (Edwards Lifesciences, California, USA). Simultaneoulsy, patients will be monitored with Enlight Electrical Impedance Tomography (Timpel, São Paulo, Brazil). Hemodynamic data will be assessed at baseline 1, one minute after the passive leg raising maneuver, after PEEP increment, and after 500 mL of Lactated Ringer's (bolus infusion). Blood gases sample will be assessed before and immediatly after the protocol.
In the ICU, immediately after CABG surgery, patients are submitted to mechanical ventilation (volume-controlled mode with tidal volume = 8mL/Kg of PBW, PEEP = 8cmH2O and FiO2 = 60%, respiratory rate to maintain PaCO2 = 35 - 45 mmHg); hemodynamically monitored with VolumeView set in combination with EV1000 clinical platform and the display of volumetric parameters (Edwards Lifesciences, California, USA). Electrical impedance tomography monitoring (Enlight, Timpel, São Paulo, Brazil) is performed with a pair of electrodes belt attached around the thorax at 4Th - 6Th intercostal space, and a flow sensor attached between the orotracheal tube and the Y connector from the ventilator.
Before initiate the protocol, patients are submitted to a bolus of usual care doses of sedation and muscular blockage (Fentanyl, Midazolam and Cisatracurium).
To assess fluid responsiveness patients will be submitted to two different maneuvers applied in a random way: Passive Leg Raising (PLR) ant PEEP increment (PEEP). And after these maneuvers patients will receive a bolus of 500 ml of Lactated Ringer's.
Measurements are performed one minute after each of these conditions:
Transpulmonary Thermodilution assessment are performed by the injection of 3 cold salines in bolus - the injection volume varied from 10 - 20mL according to the patient's actual weight and EIT assessment are performed by 1 injection of 10 mL of hypertonic saline at 7.5 - 10% according to the patient's actual weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLR group | Experimental | Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization: In PLR arm, patients will be submitted to the PLR maneuver (patient is positioned from 45 grade of semi-recumbent position to dorsal decubitus and the legs are raised at 45 grade) firstly, then PEEP increment maneuver. At the end, all patients will receive a bolus of 500mL of Lactate Ringer's |
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| PEEP group | Experimental | Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization: In PEEP arm, patients will be submitted to the PEEP maneuver (consisted in increase the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 45 grade of semi-recumbent position) firstly, then PLR maneuver. At the end, all patients will receive a bolus of 500mL of Lactate Ringer's |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive Leg Raising (PLR) and PEEP increment (PEEP) | Diagnostic Test | PLR: Fluid responsiveness maneuver which patient is positioned from 45 grade of semi-recumbent position to dorsal decubitus and the legs are raised at 45 grades; PEEP increment: Fluid responsiveness maneuver which consisted in increased the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 45 grade of semi-recumbent position |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the variation of the stroke volume and impedance variation (mean difference in %) | Mean difference between stroke volume variation and impedance variation during different fluid responsiveness maneuvers, baseline condition and after volume infusion assessed by transpulmonary thermodilution and pulse contour method for stroke volume using VolumeView system, and electrical impedance parameters measured by Electrical impedance tomography for impedance variation | within 2 hours after patient admission in the ICU |
| Correlation between the variation of the stroke volume and impedance variation | Correlation test between the change (delta) of stroke volume and impedance variation during different fluid responsiveness maneuvers, baseline condition and after volume infusion assessed by transpulmonary thermodilution and pulse contour method for stroke volume using VolumeView system, and electrical impedance parameters measured by Electrical impedance tomography for impedance variation | within 2 hours after patient admission in the ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between stroke volume variation (delta) (mean difference in %, CI and limits of agreement) | To evaluate the accuracy of the passive leg elevation (PLR) maneuver as a predictor of fluid responsiveness in the immediate postoperative of CABG, we will compare the variation in stroke volume before-and-after PLR and before-and-after the infusion of 500mL of Ringer lactate | within 2 hours after patient admission in the ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ludhmila A Hajjar, MD, PhD | Contact | 11-26615000 | 5232 | ludhmila@usp.br |
| Rafael M Ianotti, PT | Contact | 11-995989126 | rafael.ianotti@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute | Recruiting | São Paulo | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31624996 | Result | Braun F, Proenca M, Wendler A, Sola J, Lemay M, Thiran JP, Weiler N, Frerichs I, Becher T. Noninvasive measurement of stroke volume changes in critically ill patients by means of electrical impedance tomography. J Clin Monit Comput. 2020 Oct;34(5):903-911. doi: 10.1007/s10877-019-00402-z. Epub 2019 Oct 17. |
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Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization.
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| Agreement between stroke volume variation (SVV) delta during PLR maneuver and with the infusion of volume | Comparison of Stroke volume variation (SVV) delta between passive leg raising and the infusion of 500mL of Ringer Lactate (mean difference in %, CI and limits of agreement) | within 2 hours after patient admission in the ICU |
| To evaluate the ability of increment of PEEP to predict fluid responsiveness | Comparisson between change in percentage of the stroke volume measure by VolumeView, during fluid responsiveness tested by PEEP increasing, Passive leg raising, and the Gold standard, fluid infusion of 500mL of Ringer Lactate | within 2 hours after patient admission in the ICU |
| Safety of assessment stroke volume by EIT during fluid responsiveness Test (delta of Sodium, in mEq/mL) | Mean difference in the plasmatic sodium measure before and after the protocol which include 6 injection of hypertonic saline | within 2 hours after patient admission in the ICU |