Applying HPI in Oral Cancer Surgery

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

Study Overview

• Status: Not yet recruiting
• Conditions: the Severity and Duration of Intraoperative Hypotension
• Intervention / Treatment: Device: HPI; Device: HPI silence

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chih-Jun Lai, MD,PhD; Phone Number: +886965327939; Email: littlecherrytw@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• elective oral cancer surgery with free flap reconstruction

Exclusion Criteria:

• severe arrhythmia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPI; HPI guidance	Device: HPI; HPI guidance for intraoperative hypotension management
Active Comparator: HPI silence	Device: HPI silence; No HPI guidance for intraoperative hypotension management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time weight average mean arterial pressure less than 65 mmHg	a value indicating the severity and duration of intraoperative hypotension	the duration of surgery

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): January 31, 2032

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: intraoperative hypotension
• Other Study ID Numbers: 202507237RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: due to ethical concern

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No