Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU)

NCT07097454 | Completed DMC FDA Device

• 1 other identifier: WonkwangUH21
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative hypotension in the post-anesthesia care unit (PACU) is common and linked to adverse outcomes. The Hypotension Prediction Index (HPI) predicts hypotensive events intraoperatively, but its PACU application is unexplored. This study aims to investigate the effectiveness of HPI-guided monitoring in preventing PACU hypotension.

Conditions

Hypotension; Postoperative Complications

Keywords

Hypotension Prediction Index (HPI); PACU; Hemodynamic Monitoring; Arterial Pressure Waveform; HemoSphere

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Hypotension in the PACU

  Defined as mean arterial pressure (MAP) \< 65 mmHg lasting for more than 1 minute during the patient's stay in the post-anesthesia care unit (PACU).

  From PACU admission to discharge, typically within 90 minutes

Secondary Outcomes (4)

• Time to First Hypotensive Episode

  From PACU admission until first hypotensive event

• Vasopressor Use

  From PACU admission until first hypotensive episode, assessed up to 2 hours

• PACU Length of Stay

  Duration of PACU stay, typically 30 to 90 minutes

• Incidence of Postoperative Complications

  Within 24 hours after PACU admission

Study Arms (2)

HPI-guided Monitoring

EXPERIMENTAL

Participants in this group will receive continuous Hypotension Prediction Index (HPI) monitoring using the Edwards Lifesciences HemoSphere platform. Interventions such as fluid boluses or vasopressors will be administered when HPI ≥ 85, following institutional protocols.

Device: Hypotension Prediction Index Monitoring

Control Group

ACTIVE COMPARATOR

Participants in this group will receive standard post-anesthesia care unit (PACU) monitoring, including non-invasive blood pressure, heart rate, and oxygen saturation. Interventions will follow usual care without guidance from HPI.

Other: Standard PACU Monitoring

Interventions

Hypotension Prediction Index Monitoring DEVICE

HPI monitoring is performed using the Edwards Lifesciences HemoSphere platform to provide real-time hypotension prediction based on arterial pressure waveform analysis. Interventions such as fluid bolus or vasopressor are administered per protocol when HPI ≥ 85.

Also known as: HPI Monitoring

HPI-guided Monitoring

Standard PACU Monitoring OTHER

Standard monitoring in the post-anesthesia care unit (PACU), including non-invasive blood pressure, heart rate, and oxygen saturation measurements. No Hypotension Prediction Index (HPI) monitoring is used. Interventions are performed according to routine institutional practices.

Also known as: Usual Care

Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years
• Undergoing elective surgery under general anesthesia
• Presence of intra-arterial catheter at the end of surgery
• Expected PACU stay of ≥ 30 minutes
• Provided written informed consent

You may not qualify if:

• Immediate postoperative ICU admission
• Use of vasopressors during emergence from anesthesia
• ASA physical status classification of V
• Known contraindications to arterial line placement
• Participation in another interventional study within 30 days

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwag UH

Iksan, Jeollabukdo, 54538, South Korea

Location

MeSH Terms

Conditions

Hypotension; Postoperative Complications

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cheol Lee, M.D.,Ph.D

  Department of anesthesiology and pain medicine, Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking; open-label study due to the nature of real-time hemodynamic monitoring intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-arm, parallel, randomized controlled trial comparing HPI-guided monitoring versus standard care in the PACU.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 31, 2025
• Study Start: May 6, 2025
• Primary Completion: June 2, 2025
• Study Completion: July 11, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)