Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 3:23 PM
Study NCT ID:
NCT05826795
Status:
UNKNOWN
Last Update Posted:
2023-04-24
First Post:
2023-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of EGDT Using FloTrac/EV1000
Sponsor:
Khon Kaen University
Organization:
Study Overview
Official Title:
Cost-effectiveness of Applying Early Goal-directed Therapy Using FloTrac/EV1000 Platform in Patients Undergoing Coronary Artery Bypass Graft With Cardiopulmonary Bypass
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: