Nonoinvasive HPI in Beach-chair Position

NCT07554599 | Not Yet Recruiting

• 1 other identifier: 202509032RIND
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

the Brain Exygenation; the Intraoperative Hypotensionn

Outcome Measures

Primary Outcomes (1)

• the incidence of cerebral desaturation events

  whole surgery

Secondary Outcomes (1)

• the time weighted average mean arterial pressure less than 65 mmHg

  whole surgery

Study Arms (2)

HPI

OTHER

HPI guidance of hemodynamic management

Device: HPI

control

OTHER

no HPI guidance of hemodynamic management

Device: no HPI

Interventions

HPI DEVICE

non-invasive HPI

HPI

no HPI DEVICE

no non-invasive HPI

control

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Central Study Contacts

Chi-Jun Lai

CONTACT

0972652086; littlecherrytw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients and outcome assessor were masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending anesthesiologist

Model Details: HPI

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): January 31, 2032
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share