Nonoinvasive HPI in Beach-chair Position

May 4, 2026 updated by: National Taiwan University Hospital

Effect of a Non-Invasive Hypotension Prediction Index on Intraoperative Hypotension and Postoperative Complications in Elder Patients During Arthroscopic Shoulder Surgery in the Beach Chair Position

Intraoperative hypotension (defined as mean arterial pressure <65 mmHg) is a common occurrence during anesthesia and has been associated with increased risk of intraoperative hypoxia and postoperative complications, including stroke and acute kidney injury. Preventing intraoperative hypotension is therefore critical to reducing postoperative morbidity.

The number of patients undergoing arthroscopic shoulder surgery has been increasing. When performed in the beach chair position, gravitational effects reduce venous return, decrease cardiac output, and predispose patients to hypotension. Anesthetic agents further impair autonomic regulation and vascular tone, exacerbating the risk. Because the brain is positioned above the heart, cerebral perfusion pressure may decrease significantly, increasing the risk of intraoperative ischemia and postoperative neurological complications. Active monitoring and prevention of hypotension are thus essential.

The noninvasive Hypotension Prediction Index (HPI) is a novel, non-invasive tool designed to predict impending hypotensive events and guide timely intervention. While it has been evaluated in some small randomized controlled trials, there is currently a lack of RCTs specifically assessing the use of non-invasive HPI-guided management in patients undergoing arthroscopic shoulder surgery in the beach chair position.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To evaluate whether the use of non-invasive Hypotension Prediction Index-guided management reduces the duration and severity of intraoperative hypotension, as well as the incidence of intraoperative hypoxia and postoperative complications in patients undergoing arthroscopic shoulder surgery in the beach chair position.

The research team will include patients aged 65 to 90 years undergoing arthroscopic shoulder surgery in the beach chair position. Participants will be randomly assigned to either an HPI-guided group or a standard care group without HPI guidance. The duration and severity of intraoperative hypotension have been compared, as well as the incidence of postoperative complications between the two groups. Patients receiving HPI-guided management are expected to experience fewer and shorter episodes of intraoperative hypotension compared to those without HPI guidance.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Non-emergent shoulder arthroscopy performed in the beach chair position, with eligibility criteria including male or female patients aged 65-90 years.

Exclusion Criteria:

  • Women who are pregnant, planning to become pregnant during the study period, or breastfeeding
  • Individuals with major cardiac diseases, such as severe arrhythmia or heart failure
  • Individuals with significant renal disease, e.g., chronic renal failure requiring dialysis
  • Individuals with a history of stroke
  • Individuals diagnosed with dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HPI
HPI guidance of hemodynamic management
Device: HPI
non-invasive HPI
Other: control
no HPI guidance of hemodynamic management
Device: no HPI
no non-invasive HPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of cerebral desaturation events
Time Frame: whole surgery
whole surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
the time weighted average mean arterial pressure less than 65 mmHg
Time Frame: whole surgery
whole surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 27, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

January 31, 2032

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 202509032RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

due to ethical issue

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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