NCT04362033

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Ludhmila Abrahão Hajjar · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Bypass Grafting
• Fluid Therapy
• Stroke Volume
• Hemodynamic Monitoring

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-08-22
• Primary completion: 2020-04-22
• Completion: 2020-06-22
• First posted: 2020-04-24
• Last updated: 2020-04-24

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated device study