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AI vs. simple alarm: which prevents surgery danger better?

NCT ID NCT06631482

Disease control Sponsor: National Taiwan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two methods to prevent dangerously low blood pressure during surgery. One uses a new AI tool (HPI) that predicts drops in blood pressure, while the other simply raises the alarm threshold on standard monitors. About 100 adults having long surgeries will be randomly assigned to one method. The goal is to see which approach keeps blood pressure more stable and improves patient outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hypotension Prediction Index (HPI) device and elevated monitor alarm threshold
What this could lead to
If HPI works better, it could give doctors a smarter way to prevent dangerous low blood pressure during surgery, potentially improving patient recovery.
What could go wrong
This is a small, early-stage study (100 people) comparing two methods. The AI tool is expensive, and may not be better than simply raising the alarm threshold. Results may not apply to all surgeries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 \>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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypotension during surgery

Contacts and locations

Locations

  • National Taiwan University Hosipital

    Taipei, 100, Taiwan

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu, 302, Taiwan

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