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

Primary Purpose

Coronary Artery Bypass Grafting, Fluid Therapy, Stroke Volume

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Passive Leg Raising (PLR) and PEEP increment (PEEP)
Sponsored by
Ludhmila Abrahão Hajjar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Bypass Grafting focused on measuring cardiac surgery, fluid responsiveness, transpulmonary thermodilution, electrical impedance tomography, passive leg raising, stroke volume variation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PLR group

PEEP group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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)
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
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

Full Information

First Posted
January 31, 2020
Last Updated
April 23, 2020
Sponsor
Ludhmila Abrahão Hajjar
Collaborators
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04362033
Brief Title
Comparison of Dynamic Fluid Responsiveness by EIT and Transpulmonary Thermodilution in Postoperative of CABG Patients
Official Title
Comparison of Dynamic Fluid Responsiveness Assessed by Electrical Impedance Tomography and Transpulmonary Thermodilution in Postoperative of Coronary Artery Bypass Grafting Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
April 22, 2020 (Anticipated)
Study Completion Date
June 22, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ludhmila Abrahão Hajjar
Collaborators
University of Sao Paulo

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Grafting, Fluid Therapy, Stroke Volume, Hemodynamic Monitoring
Keywords
cardiac surgery, fluid responsiveness, transpulmonary thermodilution, electrical impedance tomography, passive leg raising, stroke volume variation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLR group
Arm Type
Experimental
Arm Description
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
Arm Title
PEEP group
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Passive Leg Raising (PLR) and PEEP increment (PEEP)
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference between the variation of the stroke volume and impedance variation (mean difference in %)
Description
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
Time Frame
within 2 hours after patient admission in the ICU
Title
Correlation between the variation of the stroke volume and impedance variation
Description
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
Time Frame
within 2 hours after patient admission in the ICU
Secondary Outcome Measure Information:
Title
Agreement between stroke volume variation (delta) (mean difference in %, CI and limits of agreement)
Description
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
Time Frame
within 2 hours after patient admission in the ICU
Title
Agreement between stroke volume variation (SVV) delta during PLR maneuver and with the infusion of volume
Description
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)
Time Frame
within 2 hours after patient admission in the ICU
Title
To evaluate the ability of increment of PEEP to predict fluid responsiveness
Description
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
Time Frame
within 2 hours after patient admission in the ICU
Title
Safety of assessment stroke volume by EIT during fluid responsiveness Test (delta of Sodium, in mEq/mL)
Description
Mean difference in the plasmatic sodium measure before and after the protocol which include 6 injection of hypertonic saline
Time Frame
within 2 hours after patient admission in the ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ludhmila A Hajjar, MD, PhD
Phone
11-26615000
Ext
5232
Email
ludhmila@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael M Ianotti, PT
Phone
11-995989126
Email
rafael.ianotti@gmail.com
Facility Information:
Facility Name
Heart Institute
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludhmila A Hajjar, MD, PhD
Phone
11-26615232
Email
ludhmila@usp.br
First Name & Middle Initial & Last Name & Degree
Rafael Ianotti, PT
Phone
11-995989126
Email
rafael.ianotti@gmail.com
First Name & Middle Initial & Last Name & Degree
Ludhmila A Hajjar, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rafael M Ianotti, PT
First Name & Middle Initial & Last Name & Degree
Marcelo P Amato, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31624996
Citation
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.
Results Reference
result

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

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