Efficacy of Acumen HPI system

JRCT ID: jRCT1012220033

Registered date:29/12/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-cardiac surgery
• Date of first enrollment: 13/02/2023
• Target sample size: 64
• Study type: Interventional

Intervention(s)

-Hemodynamic monitoring with arterial line-
Goal directed therapy is performed with Acumen HPI system (Edwards Life Science, 30400BZX00002000) during surgery.
-Administration of hemodynamic drugs based on a protocol-
Fluid therapy with crystalloid and colloid fluid and hemodynamic drugs including ephedrine (5-10 mg) and phenylephrine (0.05-0.1 mg) are applied for goal directed therapy.

Outcome(s)

• Primary Outcome: Intraoperative time weighted average (TWA) (mean arterial pressure < 65 mmHg)

Secondary Outcome

Incidence of hypotension, total number of hypotensive events, average duration of each hypotensibe event, total duration of hypotension, mean MAP under 65 mmHg,
area under 65 mmHg for MAP, number of patients that experience an event under 50 mmHg, patients background, anesthetic and surgical factors, dose of hemodynamic drugs, volume of infusion and transfusion, hemodynamic parameters, BGA, admission days, 30-day mortality

Key inclusion & exclusion criteria

• Age minimum: >= 45age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

equal to or older than 45 years old
Patients who receive non-cardiac surgery under general anesthesia
Patients who are scheduled to be managed with arterial line

Exclude criteria

Emergent surgery
Vascular surgery, hepatic sugery, neurosurgery
Thoracic surgery, surgery with prone position, severe valvular disease, arrhythmia, intracardiac shunt, chronic hemodyalisis
Other patients who are considered inappropriate for the study by the attending anesthesiologists

Related Information

• Primary Sponsor: Yoshikawa Yusuke