Comparison Bewteen Intraoperative HPI vs. High Mean Arterial Pressure Threshold

NCT06631482 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 202406137RIND
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypotension During Surgery

Keywords

HPI; intraopeartive hypotension; overtreatment

Outcome Measures

Primary Outcomes (2)

• Comparison of Time-Weighted Average (TWA) for MAP below 65 mmHg During Surgery

  The primary outcome will assess the time-weighted average (TWA) for both groups, comparing the duration and magnitude of mean arterial pressure (MAP) below 65 mmHg during surgery. This will help determine the effectiveness of the interventions in preventing intraoperative hypotension and hypertension.

  From the start of surgery to the end of surgery, approximately up to 12 hours, depending on the duration of the operation.

• Comparison of Time-Weighted Average (TWA) for MAP above 100 mmHg During Surgery

  The primary outcome will assess the time-weighted average (TWA) for both groups, comparing the duration and magnitude of mean arterial pressure (MAP) above 100 mmHg during surgery. This will help determine the effectiveness of the interventions in preventing intraoperative hypotension and hypertension.

  From the start of surgery to the end of surgery, approximately up to 12 hours, depending on the duration of the operation.

Secondary Outcomes (3)

• 30-day mortality rate

  From the day of surgery to 30 days postoperatively.

• dosage of intraoperative interventions (such as vasopressors and fluids)

  During the surgery (from induction of anesthesia to the end of surgery, approximately up to 12 hours, depending on the duration of the surbery).

• hospital stay

  Approximately 7 days from the date of enrollment

Study Arms (2)

HPI Group

EXPERIMENTAL

Use the hypotension predictive index (HPI)-guided protocol to prevent intraoperative hypotension, initiating treatmentusing the fluid administration or intravenous norepinephrine infusion to keep intraoperative HPI below 85.

Device: Maintain HPI < 85

73mmHg MAP Alarm Group

ACTIVE COMPARATOR

Intraoperative maintenance of the mean arterial pressure (MAP) at 73 mmHg or higher by using the fluid administration or intravenous norepinephrine infusion.

Drug: Maintain MAP>=73

Interventions

Maintain HPI < 85 DEVICE

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.

HPI Group

Maintain MAP>=73 DRUG

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.

73mmHg MAP Alarm Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A: Patients undergoing surgeries requiring general anesthesia lasting more than two hours, and requiring continuous arterial blood pressure monitoring via arterial catheter according to standard medical practice. This includes:
• ASA Class II or higher. Estimated surgery duration of three hours or more. High cardiovascular risk, such as poorly controlled hypertension, diabetes, coronary artery disease, chronic kidney disease, or chronic emphysema.
• B: Patients aged 18 years or older.

You may not qualify if:

• ASA Class I: Patients with mild systemic disease.
• Pregnancy: Pregnant women.
• End-stage renal disease: Patients with eGFR below 30 ml/min/1.73 m².
• Cardiac shunt: Presence of intracardiac shunt.
• Severe arrhythmias: Including supraventricular tachycardia (heart rate \&amp;amp;gt;100 bpm), ventricular tachycardia, or ventricular fibrillation.
• Factors affecting SVV accuracy: Conditions such as atrial fibrillation (A-Fib) or thoracic surgery that can invalidate stroke volume variation (SVV) measurements.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hosipital

Taipei, 100, Taiwan

Location

National Taiwan University Hospital Hsin-Chu Branch

Taoyuan District, 302, Taiwan

Location

Related Publications (2)

• Mulder MP, Harmannij-Markusse M, Fresiello L, Donker DW, Potters JW. Hypotension Prediction Index Is Equally Effective in Predicting Intraoperative Hypotension during Noncardiac Surgery Compared to a Mean Arterial Pressure Threshold: A Prospective Observational Study. Anesthesiology. 2024 Sep 1;141(3):453-462. doi: 10.1097/ALN.0000000000004990.

  PMID: 38558038 BACKGROUND

• Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.

  PMID: 29894315 BACKGROUND

Study Officials

• Tsung Ta Wu, MD.

  National Taiwan University Hospital Hsinchu branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 8, 2024
• Study Start: September 16, 2024
• Primary Completion: October 14, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)