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NCT Number: NCT07405892

Applying HPI in Oral Cancer Surgery

Investigating HPI effect in oral cancer surgery

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective oral cancer surgery with free flap reconstruction

Exclusion criteria

  • severe arrhythmia

Treatment and study plan

HPI

Device

HPI guidance for intraoperative hypotension management

HPI silence

Device

No HPI guidance for intraoperative hypotension management

Primary outcomes

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

    Time frame: the duration of surgery

    a value indicating the severity and duration of intraoperative hypotension

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Jun Lai, MD,PhD

CONTACT

[email protected]

+886965327939

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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