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ACTIVE NOT RECRUITING
NCT06631482
NA

Comparison Bewteen Intraoperative HPI vs. High Mean Arterial Pressure Threshold

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

Intraoperative hypotension (IOH) is a common and serious complication during surgery, closely associated with poor postoperative outcomes. Traditionally, anesthesiologists rely on real-time physiological parameters and alarms to monitor blood pressure, but the low alarm thresholds may lead to delayed interventions. The Hypotension Prediction Index (HPI) is a novel predictive tool that uses arterial waveform signals and advanced algorithms to forecast hypotensive events in advance. Recent observational studies have shown that HPI's accuracy in predicting hypotension is highly consistent with setting the physiological monitor's alarm threshold to 73 mmHg. This study will compare the effectiveness of HPI and a raised alarm threshold of 73 mmHg in preventing IOH. While HPI is promising with its AI-assisted approach to patient care, its high cost due to the advanced technology raises concerns. If its accuracy is comparable to simply raising the traditional monitor threshold, it may not lead to substantial changes in clinical practice.

Official title: Randomized Controlled Trial Comparing HPI and Elevated Threshold Monitor Alarms in Preventing Intraoperative Hypotension

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-09-16

Completion Date

2026-05-31

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DEVICE

Maintain HPI < 85

Protocolized treatment with fluid administration, norepinephrine, and dobutamine to prevent intraoperative hypotension. The two arms are triggered by different alarms: one from a traditional monitor with an elevated MAP threshold of 73 mmHg, and the other from an HPI threshold of 85.

DRUG

Maintain MAP>=73

Protocolized treatment with fluid administration, norepinephrine, and dobutamine to prevent intraoperative hypotension. The two arms are triggered by different alarms: one from a traditional monitor with an elevated MAP threshold of 73 mmHg, and the other from an HPI threshold of 85.

Locations (2)

National Taiwan University Hosipital

Taipei, Taiwan

National Taiwan University Hospital Hsin-Chu Branch

Taoyuan District, Taiwan