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

NCT04362033 | Unknown FDA Device

• 1 other identifier: 90728718.7.0000.0068
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Agreement between stroke volume variation (delta) (mean difference in %, CI and limits of agreement)

  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

  within 2 hours after patient admission in the ICU

• To evaluate the ability of increment of PEEP to predict fluid responsiveness

  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)

  within 2 hours after patient admission in the ICU

Study Arms (2)

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

Diagnostic Test: Passive Leg Raising (PLR) and PEEP increment (PEEP)

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

Diagnostic Test: Passive Leg Raising (PLR) and PEEP increment (PEEP)

Interventions

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

PEEP group; PLR group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ludhmila Abrahão Hajjar: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Heart Institute

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 31624996 RESULT

Central Study Contacts

Ludhmila A Hajjar, MD, PhD

CONTACT

11-26615000; ludhmila@usp.br

Rafael M Ianotti, PT

CONTACT

11-995989126; rafael.ianotti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Cardiology Department

Model Details: Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: April 24, 2020
• Study Start: August 22, 2018
• Primary Completion: April 22, 2020
• Study Completion: June 22, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)