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the Severity and Duration of Intraoperative HypotensionNCT07405892

Applying HPI in Oral Cancer Surgery

A study testing HPI and HPI silence in people with the Severity and Duration of Intraoperative Hypotension, run by National Taiwan University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Investigating HPI effect in oral cancer surgery Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
HPI and HPI silence
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
31 Oct 2026to 31 Jan 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • elective oral cancer surgery with free flap reconstruction

Who cannot join

  • severe arrhythmia

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Chih-Jun Lai, MD,PhD contact

+886965327939

littlecherrytw@gmail.com

About this study

Official title: The Impact of Hypotension Prediction Index-Guided Management on Intraoperative Hypotension and Major Postoperative Complications in Patients Undergoing Oral Cancer Resection and Reconstruction

Investigating HPI effect in oral cancer surgery

Read the detailed description

Intraoperative hypotension, defined as a mean arterial pressure (MAP) below 65 mmHg, is common during oral cancer resection with reconstruction-a lengthy procedure averaging 13 hours. Prolonged anesthesia increases the risk of intraoperative hypotension, which would lead to a higher need for vasopressor administration and fluid transfusion. Additionally, surgical anastomosis sites are vulnerable, and hypotension has been linked to increased risks of anastomotic necrosis, septic shock, organ failure, and mortality.

The Hypotension Prediction Index (HPI) is a machine-learning-based algorithm introduced in 2019 that analyzes arterial pressure waveform characteristics to provide real-time monitoring and early prediction of hypotensive episodes-defined as a MAP <65 mmHg lasting for at least one minute-during surgery. Recent randomized controlled trials have evaluated the effectiveness of HPI-guided management in preventing intraoperative hypotension. These studies commonly use the "time-weighted average (TWA) MAP <65 mmHg" as the primary outcome, calculated as the area under the threshold (in mmHg×hours) divided by the total duration of surgery (in hours). The lower the value, the shorter and less severe the intraoperative hypotension. However, limited studies have specifically investigated the impact of HPI-guided management on the duration and severity of intraoperative hypotension and postoperative complications in patients undergoing oral cancer resection with reconstruction.This study aims to evaluate the effectiveness of HPI-guided management in reducing the duration and severity of intraoperative hypotension in patients undergoing oral cancer resection with free flap reconstruction. The investigator hypothesize that the TWA-MAP <65 mmHg will be significantly lower in the HPI-guided group compared to the standard care group. Postoperative major complications will be followed during postoperative 30 days. One hundred patients aged 20 to 80 years undergoing elective oral cancer resection with free flap reconstruction will be randomized to receive hemodynamic management with or without HPI guidance. Clinicians caring for patients assigned to the HPI guidance group will be alerted when the index exceeded 85 (range 0 to 100) indicating the later occurrence of MAP< 65mmHg for at least minutes and a treatment protocol based on advanced hemodynamic parameters recommended vasopressor or inotrope, fluid administration, or observation. Primary outcome is the data of TWA-MAP<65mmHg. Postoperative complications and mortality will be followed up to postoperative 30 days.

Being tested
HPI, HPI silence
Keywords
intraoperative hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPIDevice

    HPI guidance for intraoperative hypotension management

  • HPI silenceDevice

    No HPI guidance for intraoperative hypotension management

Study groups in NCT07405892
Study groupRoleWhat they receive
HPIExperimentalHPI guidance
Receives: Device: HPI
HPI silenceActive comparatorHPI silence
Receives: Device: HPI silence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time weight average mean arterial pressure less than 65 mmHg

    a value indicating the severity and duration of intraoperative hypotension

    Measured: the duration of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start31 Oct 2026 (estimated)
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
intervention: HPI guidance; control: HPI silence
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07405892
Sponsor's protocol ID
202507237RINB
Status last verified
Jan 2026
First submitted
21 Jan 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: due to ethical concern

Questions about this trial

What is this clinical trial studying?

A study testing HPI and HPI silence in people with the Severity and Duration of Intraoperative Hypotension, run by National Taiwan University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chih-Jun Lai, MD,PhD (+886965327939, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time weight average mean arterial pressure less than 65 mmHg (time frame: the duration of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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