HypotensionNCT07097454
Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU)
A study testing Hypotension Prediction Index Monitoring and Standard PACU Monitoring in people with Hypotension and Postoperative Complications, run by Wonkwang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypotension, Postoperative Complications
- What is being tested?
- Hypotension Prediction Index Monitoring and Standard PACU Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jul 2026to 11 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU): A Prospective, Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Hypotension, Postoperative Complications
- Being tested
- Hypotension Prediction Index Monitoring, Standard PACU Monitoring
- Keywords
- Hypotension Prediction Index (HPI), PACU, Hemodynamic Monitoring, Arterial Pressure Waveform, HemoSphere
- Medical subject headings
- Hypotension, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension Prediction Index MonitoringDevice
Also called HPI 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.
Standard PACU MonitoringOther
Also called Usual Care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard PACU Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From PACU admission to discharge, typically within 90 minutes
Secondary outcomes (4)
Time to First Hypotensive Episode
Time elapsed from PACU admission to the first hypotensive episode (MAP < 65 mmHg for >1 minute).
Measured: From PACU admission until first hypotensive event
Vasopressor Use
Percentage of patients receiving any vasopressor during PACU stay.
Measured: From PACU admission until first hypotensive episode, assessed up to 2 hours
PACU Length of Stay
Total duration (in minutes) of PACU stay.
Measured: Duration of PACU stay, typically 30 to 90 minutes
Incidence of Postoperative Complications
Occurrence of postoperative complications during PACU stay, including nausea/vomiting and acute kidney injury as defined by KDIGO criteria.
Measured: Within 24 hours after PACU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start2 Jul 2026
- Primary completion16 Jul 2026
- Study completion11 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel, randomized controlled trial comparing HPI-guided monitoring versus standard care in the PACU.
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee,MD,PhD,, Wonkwang University Hospital
- Investigators
- Cheol Lee, M.D.,Ph.D, Principal investigator, Department of anesthesiology and pain medicine, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097454
- Sponsor's protocol ID
- WonkwangUH21
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU): A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07097454
- Acronym / sponsor ID
- WonkwangUH21
- Conditions
- Hypotension, Postoperative Complications
- Keywords
- Hypotension Prediction Index (HPI), PACU, Hemodynamic Monitoring, Arterial Pressure Waveform, HemoSphere
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 11 Aug 2026 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel, randomized controlled trial comparing HPI-guided monitoring versus standard care in the PACU.
| Arm | Type | Receives |
|---|---|---|
| HPI-guided Monitoring | Experimental | Device: Hypotension Prediction Index MonitoringParticipants 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. |
| Control Group | Active comparator | Other: Standard PACU MonitoringParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypotension Prediction Index MonitoringAlso: HPI MonitoringHPI 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. | Device | HPI-guided Monitoring |
| Standard PACU MonitoringAlso: Usual CareStandard 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 | Control Group |
Primary outcome
Incidence of Postoperative Hypotension in the PACU
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).
4 secondary outcomes
Time to First Hypotensive Episode
Time frame: From PACU admission until first hypotensive event
Vasopressor Use
Time frame: From PACU admission until first hypotensive episode, assessed up to 2 hours
PACU Length of Stay
Time frame: Duration of PACU stay, typically 30 to 90 minutes
Incidence of Postoperative Complications
Time frame: Within 24 hours after PACU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheol Lee, M.D.,Ph.D principal investigator
Department of anesthesiology and pain medicine, Wonkwang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypotension Prediction Index Monitoring and Standard PACU Monitoring in people with Hypotension and Postoperative Complications, run by Wonkwang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Hypotension in the PACU (time frame: From PACU admission to discharge, typically within 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.