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

Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU): A Prospective, Randomized, Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07097454
Enrollment
210
Registered
2025-07-31
Start date
2026-07-02
Completion date
2026-08-11
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Postoperative Complications

Keywords

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

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.

Detailed description

Study Design This prospective, randomized, controlled, single-center trial will be conducted in the PACU of a tertiary care hospital. The study aims to evaluate the effectiveness of HPI in preventing postoperative hypotension. All procedures follow institutional protocols, and the trial is designed to reduce bias through randomization and stratification. Study Population Eligible patients are adults (≥ 19 years) undergoing elective surgery under general anesthesia, with arterial catheters in place and an expected PACU stay of ≥ 30 minutes. Exclusion criteria include immediate postoperative ICU admission, use of vasopressors during anesthesia emergence, ASA physical status V, or contraindications to arterial monitoring. These criteria ensure a focus on patients suitable for PACU monitoring with arterial lines. The study population is representative of high-risk surgical patients requiring advanced hemodynamic monitoring. Intervention Patients will be randomized 1:1 to the HPI group, which receives continuous HPI monitoring (Edwards Lifesciences HemoSphere platform, Irvine, CA, USA) with interventions such as fluid boluses or vasopressors if HPI is ≥ 85 per protocol, or to the control group, which receives standard PACU monitoring including non-invasive blood pressure, heart rate, and oxygen saturation. The interventions in the HPI group follow institutional guidelines to ensure consistency, while the control group receives routine PACU monitoring practices. Randomization will be used in a computer-generated sequence, stratified by ASA class (I-II vs. III-IV) to balance risk profiles. Outcomes The primary outcome is the incidence of hypotension (mean arterial pressure \[MAP\] \< 65 mmHg for more than 1 minute) during the PACU stay. Secondary outcomes include time to the first hypotensive episode, total duration of hypotension, vasopressor and fluid administration (frequency and dose), PACU stay duration, and postoperative complications such as nausea and acute kidney injury. Acute kidney injury (AKI) in the PACU was defined using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, specifically as an increase in serum creatinine by ≥ 0.3 mg/dL within 48 hours of surgery or an increase to ≥1.5 times baseline within 7 days, assess via blood samples collect during or immediately after the PACU stay. Urine output criteria are not used due to the short PACU duration and inconsistent catheterization. These outcomes are selected to evaluate both the effectiveness and impact of the HPI on clinical management. Complications are monitored to assess safety and secondary effects.

Interventions

DEVICEHypotension Prediction Index Monitoring

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.

OTHERStandard PACU Monitoring

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.

Sponsors

Wonkwang University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

No masking; open-label study due to the nature of real-time hemodynamic monitoring intervention.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative Hypotension in the PACUFrom PACU admission to discharge, typically within 90 minutesDefined 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).

Secondary

MeasureTime frameDescription
Time to First Hypotensive EpisodeFrom PACU admission until first hypotensive eventTime elapsed from PACU admission to the first hypotensive episode (MAP \< 65 mmHg for \>1 minute).
Vasopressor UseFrom PACU admission until first hypotensive episode, assessed up to 2 hoursPercentage of patients receiving any vasopressor during PACU stay.
PACU Length of StayDuration of PACU stay, typically 30 to 90 minutesTotal duration (in minutes) of PACU stay.
Incidence of Postoperative ComplicationsWithin 24 hours after PACU admissionOccurrence of postoperative complications during PACU stay, including nausea/vomiting and acute kidney injury as defined by KDIGO criteria.

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORCheol Lee, M.D.,Ph.D

Department of anesthesiology and pain medicine, Wonkwang University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026