Wonkwag UH
Iksan, Jeollabukdo, 54538, South Korea
Location status: Recruiting
NCT Number: NCT07097454
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
Iksan, Jeollabukdo, 54538, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: HPI 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.
Other names: Usual Care
Time frame: From PACU admission to discharge, typically within 90 minutes
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).
Time frame: From PACU admission until first hypotensive event
Time elapsed from PACU admission to the first hypotensive episode (MAP < 65 mmHg for >1 minute).
Time frame: From PACU admission until first hypotensive episode, assessed up to 2 hours
Percentage of patients receiving any vasopressor during PACU stay.
Time frame: Duration of PACU stay, typically 30 to 90 minutes
Total duration (in minutes) of PACU stay.
Time frame: Within 24 hours after PACU admission
Occurrence of postoperative complications during PACU stay, including nausea/vomiting and acute kidney injury as defined by KDIGO criteria.
Contact information is provided by the study sponsor or research team.
Cheol Lee, M.D.,Ph.D.
CONTACT
Cheolhyeong Lee, M.D.
CONTACT
Wonkwang University Hospital
Other
Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU): A Prospective, Randomized, Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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