Comparison of Dynamic Fluid Responsiveness by EIT and Transpulmonary Thermodilution in Postoperative of CABG Patients

Comparison of Dynamic Fluid Responsiveness Assessed by Electrical Impedance Tomography and Transpulmonary Thermodilution in Postoperative of Coronary Artery Bypass Grafting Patients

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.

Study Overview

• Status: Unknown
• Conditions: Hemodynamic Monitoring; Fluid Therapy; Coronary Artery Bypass Grafting; Stroke Volume
• Intervention / Treatment: Diagnostic test: Passive Leg Raising (PLR) and PEEP increment (PEEP)

Detailed Description

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:

• Baseline: before both fluid responsiveness maneuvers, before and after Lactated Ringer infusion, patient is positioned in 450 semi-recumbent position;
• PLR: Fluid responsiveness maneuver which patient is positioned from 450 semi-recumbent position to dorsal decubitus and the legs are raised at 450;
• PEEP increment: Fluid responsiveness maneuver which consisted in increased the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 450 semi-recumbent position
• Infusion of 500 mL of Ringer's; 450 semi-recumbent position.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403000
      • Recruiting
      • Heart Institute
      • Contact: Ludhmila A Hajjar, MD, PhD; Phone Number: 11-26615232; Email: ludhmila@usp.br
      • Contact: Rafael Ianotti, PT; Phone Number: 11-995989126; Email: rafael.ianotti@gmail.com
      • Principal Investigator: Ludhmila A Hajjar, MD, PhD
      • Sub-Investigator: Rafael M Ianotti, PT
      • Sub-Investigator: Marcelo P Amato, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective CABG surgery
• Age greater than 18 years old and less than 80 years old
• Written inform consent

Exclusion Criteria:

• Previous pulmonary disease or pulmonary hypertension
• Previous renal replacement therapy
• Left ventricular ejection fraction < 40%
• Body mass index > 40 kg/m2
• Atrial fibrillation
• Presence of cardiac pacemaker or another implantable electronic device
• Bleeding associated to hemodynamic instability
• Cardiac arrest or suspicion of neurological alteration
• Hemodynamic instability (norepinephrine dose > 0.5 mcg/Kg/min)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLR group; 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	Diagnostic test: Passive Leg Raising (PLR) and PEEP increment (PEEP); 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
Experimental: PEEP group; 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	Diagnostic test: Passive Leg Raising (PLR) and PEEP increment (PEEP); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Ludhmila Abrahão Hajjar
• Collaborators: University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2018
• Primary Completion (Anticipated): April 22, 2020
• Study Completion (Anticipated): June 22, 2020

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: cardiac surgery; fluid responsiveness; electrical impedance tomography; stroke volume variation; transpulmonary thermodilution; passive leg raising
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 90728718.7.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes