Cost-effectiveness of EGDT Using FloTrac/EV1000

Khon Kaen University

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: Early goal-directed therapy (EGDT)

Study type: Observational

Funder types: Other

Identifiers

NCT05826795

HE631648

Details and patient eligibility

About

Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) is a high-risk surgery with significant morbidity that results in a prolonged stay in the intensive care unit (ICU) at an increased cost. Early goal-directed therapy (EGDT) using the FloTrac/EV1000 platform improved outcomes in these patients with shorter ICU stay but with extra cost for a FloTrac transducer. The objective of this study is to assess the cost-effectiveness of implementing the FloTrac/EV1000 in these patients.

Full description

EGDT using FloTrac/EV1000 platform has been reported to improve outcomes in patients undergoing CABG with CPB resulting in a reduction in cardiovascular and thoracic ICU (CVT ICU) and hospital stay. However, the use of the FloTrac sensor has an extra cost that impedes its implementation. There is still no study that assesses the cost-effectiveness of implementing FloTrac in cardiac surgery.

The objective of our study is to evaluate the cost-effectiveness of applying EGDT using the FloTrac/EV1000 platform in patients undergoing CABG with CPB.

There are 2 steps in this study:

1. Assessing the efficacy of the FloTrac/EV1000 platform
2. Assessing the daily CVT ICU cost

Assessing the efficacy of the FloTrac/EV1000 platform

We compare the efficacy of the FloTrac/EV1000 versus standard practice. The sample size of 30 patients per group was calculated based on data from a previous study, an α value of 0.05, a β value of 0.2, and a 30% decrease in ICU stay. Sixty patients undergoing CABG with CPB at Srinagarind Hospital or Queen Sirikit Heart Center of the Northeast between July 2018 and June 2020 will be recruited. They will be divided into 2 groups: EV1000 and Control. The intraoperative hemodynamic optimization in the EV1000 was managed using goal-directed therapy via the FloTrac/EV1000 platform and the Control was managed using a standard protocol as described in the study of Tribuddharat et al. The extracted data for comparison were: demographic and clinical data, CVT ICU stay, ventilator time in CVT ICU, postoperative complications, and hospital stay. The ICU stay of both groups will be compared.

Assessing the daily CVT ICU cost

We will evaluate the ICU cost of the CVT ICU of Srinagarind Hospital by recruiting another group of patients who were admitted to the CVT ICU during October 2021 to identify the average daily cost. The cost of a FloTrac sensor and the ICU cost saved will be compared.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients who underwent CABG with CPB.

Exclusion criteria

• Patients who required an intra-aortic balloon pump or extracorporeal membrane oxygenator.

Trial design

60 participants in 2 patient groups

Control

Description:

During the intraoperative period, both before and after CPB, the Control group received fluid, inotropic, and/or vasoactive drugs at the discretion of the attending anesthesiologists to achieve the following goals: MAP 65-90 mmHg; CVP 8-12 mmHg; urine output ≥ 0.5 mL·kg-1·h-1; SpO2 \> 95%; and hematocrit 26-30%. Arterial blood gas (ABG) and electrolytes were monitored and corrected hourly.

EV1000

Description:

The patients were managed to achieve similar goals: MAP 65-90 mmHg; urine output ≥ 0.5 mL·kg-1·h-1; SpO2 \> 95%; and hematocrit 26-30%, using information from the FloTrac/EV1000. The EGDT group received: fluid to maintain a SVV \< 13%; inotropic drugs to achieve a SVI of 33-65 mL·beat-1·m-2 and CI of 2.2-4.0 L·min-1·m-2; and/or vasoactive drugs to achieve a SVRI of 1600-2500 dynes·s·cm-5·m-2. ABG and electrolytes were monitored and corrected in the same manner.

Treatment:

Procedure: Early goal-directed therapy (EGDT)