Dynamic Tests and Parameters to Predict Fluid Responsiveness After OPCAB

Dynamic Tests and Parameters to Predict Fluid Responsiveness After Off-pump Coronary Artery Bypass Grafting

Objective: To assess the predictive value of dynamic tests and parameters for evaluation of fluid responsiveness after off-pump coronary artery bypass grafting (OPCAB).

After arrival to ICU, all patients received positive end-expiratory pressure test (PEEP-test), mini-fluid challenge test (mFCT) and standard fluid challenge test (sFCT) to assess fluid responsiveness. In addition, investigators measured pulse pressure variation using two monitoring systems (PPVPiCCO and PPVNK), stroke volume variation (SVV), heart-lung interaction index (HLI) and plethysmogram variability index (PVI) before and after sFCT.

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery
• Intervention / Treatment: Diagnostic test: Assessment of fluid responsiveness

Detailed Description

All patients were intubated using the standard induction technique with sodium thiopental (4 mg/kg), fentanyl (2.5-3.0 mcg/kg) and pipecuronium bromide (0.1 mg/kg). Anaesthesia was maintained using sevoflurane (0.5-3.0 vol.% at the end of expiration) and fentanyl (2.0-4.0 mcg/kg/hr). Depth of anaesthesia was adjusted to maintain bispectral index (BIS) values between 40-60 (LifeScope, Nihon Kohden, Japan).

In all cases, preoxygenation with 80% O2 was provided during 3-5 minutes before anesthesia. After tracheal intubation, patients were ventilated using a protective volume-controlled mode (Dräger Primus, Germany) with tidal volume of 6-8 mL/kg of predicted body weight, flow of 1 L/min and positive end-expiratory pressure (PEEP) of 5 cm H2O. The value of FiO2 was set to at least 50% or higher to achieve intraoperative SpO2 above 95%. The respiratory rate was adjusted to maintain end-tidal CO2 values within 30-35 mm Hg.

All the patients were operated by the same team of surgeons using Acrobat SUV OM-9000S (Guidant, Santa Clara, USA) device for stabilization of the heart during revascularization.

After surgery, all patients were transferred to the postoperative cardiac ICU and sedated during 60 min with continuous infusion of propofol (2-4 mcg/kg/hr) to maintain BIS values within 60-70. Respiratory support in ICU was continued by a G5 ventilator (Hamilton Medical, Switzerland) using pressure controlled ventilation mode with parameters same as for intraoperative period.

Investigators provided invasive hemodynamic monitoring (PiCCO2, Pulsion Medical Systems, Germany; Nihon Kohden, MU-671RK, Japan) to all patients. After the initial stabilization of patient, investigators performed three dynamic tests in a consequent order. The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O during 120 seconds. The PEEP-test was interrupted if mean arterial pressure (MAP) decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. During PEEP-test and mFCT, investigators performed continuous monitoring of MAP, SVV, PPV and PCCI (PiCCO2). Investigators also measured SVV, PPVPiCCO, PVVNK (Nihon Kohden), HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) before and after sFCT. In addition, investigators assessed cardiac index (CI), extravascular lung water index (EVLWI) and global end-diastolic volume index (GEDVI) using transpulmonary thermodilution (PiCCO2). During the study, investigators measured arterial blood gases and lactate concentration. The patients who demonstrated an increase in CI ≥ 15 % after sFCT were defined as fluid responders.10, 11 After the initial measurements, sedation was stopped, and the weaning from respiratory support was initiated. The weaning protocol included gradual decrease of inspiratory pressure and mandatory respiratory rate followed by spontaneous breathing trial after achieving pressure support of 8 cm H2O. After passing the 30-min spontaneous breathing trial, all the patients were extubated and received oxygen inhalation via facial mask.

In addition to hemodynamic and respiratory parameters, recorded the preoperative EuroScore II, duration of postoperative mechanical ventilation, length of ICU stay and fluid balance after OPCAB and on postoperative Day 1.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation, 163000
    • Recruiting
    • City Hospital # 1 n.a. E.E. Volosevich
    • Contact: Mikhail Kirov, PhD; Email: mikhail_kirov@hotmail.com

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 OPCAB

Exclusion Criteria:

morbid obesity with body mass index > 40 kg/m2 constant atrial fibrillation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Assessment of fluid responsiveness; The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O for 120 seconds. The PEEP-test was interrupted if MAP decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. Investigators performed monitoring of mean arterial pressure (MAP), SVV and PPVPiCCO using femoral artery (PiCCO2). Investigators also assessed PVVNK using radial artery and Nihon Kohden patient monitor. HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) were assessed non-invasively, using finger probes.

Diagnostic test: Assessment of fluid responsiveness; The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O for 120 seconds. The PEEP-test was interrupted if MAP decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. Investigators performed monitoring of mean arterial pressure (MAP), SVV and PPVPiCCO using femoral artery (PiCCO2). Investigators also assessed PVVNK using radial artery and Nihon Kohden patient monitor. HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) were assessed non-invasively, using finger probes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of dynamic tests	To assess if changes in mean arterial pressure, pulse pressure variation and stroke volume variation by more than 10% during the PEEP-test and mini fluid challenge test can predict the increment of the cardiac output on more than 15 % during standard fluid challenge test after off-pump coronary artery bypass grafting (OPCAB).	immediately postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of dynamic parameters	To assess the ability of the decrement of Pulse pressure variation (measured by Nikhon), Heart-lung interaction index (HLI) and Pulse variability index (PVI) by more than 3% to predict the increment of the cardiac output on more than 15 % during standard fluid challenge test after off-pump coronary artery bypass grafting (OPCAB).	immediately postoperatively

Collaborators and Investigators

• Sponsor: Northern State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: fluid responsiveness; dynamic tests; dynamic parameters
• Other Study ID Numbers: Dyn Test-and-Index

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: No