NCT07405892

Brief Summary

Investigating HPI effect in oral cancer surgery

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
70mo left

Started Feb 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Feb 2026Jan 2032

First Submitted

Initial submission to the registry

January 21, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2032

Last Updated

February 12, 2026

Status Verified

January 1, 2026

Enrollment Period

5.9 years

First QC Date

January 21, 2026

Last Update Submit

February 8, 2026

Conditions

the Severity and Duration of Intraoperative Hypotension

Keywords

intraoperative hypotension

Outcome Measures

Primary Outcomes (1)

  • time weight average mean arterial pressure less than 65 mmHg

    a value indicating the severity and duration of intraoperative hypotension

    the duration of surgery

Study Arms (2)

HPI

EXPERIMENTAL

HPI guidance

Device: HPI

HPI silence

ACTIVE COMPARATOR

HPI silence

Device: HPI silence

Interventions

HPIDEVICE

HPI guidance for intraoperative hypotension management

HPI
HPI silenceDEVICE

No HPI guidance for intraoperative hypotension management

HPI silence

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective oral cancer surgery with free flap reconstruction

You may not qualify if:

  • severe arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Chih-Jun Lai, MD,PhD

CONTACT

+886965327939littlecherrytw@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients were blinded to their group allocation, and outcome assessors were also blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: intervention: HPI guidance; control: HPI silence
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 12, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

January 31, 2032

Last Updated

February 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

due to ethical concern