the Intraoperative HypotensionnNCT07554599
Nonoinvasive HPI in Beach-chair Position
A study testing HPI and no HPI in people with the Intraoperative Hypotensionn and the Brain Exygenation, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- the Intraoperative Hypotensionn, the Brain Exygenation
- What is being tested?
- HPI and no HPI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2026to 31 Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Non-emergent shoulder arthroscopy performed in the beach chair position, with eligibility criteria including male or female patients aged 65-90 years.
Who cannot join
- Women who are pregnant, planning to become pregnant during the study period, or breastfeeding
- Individuals with major cardiac diseases, such as severe arrhythmia or heart failure
- Individuals with significant renal disease, e.g., chronic renal failure requiring dialysis
- Individuals with a history of stroke
- Individuals diagnosed with dementia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of a Non-Invasive Hypotension Prediction Index on Intraoperative Hypotension and Postoperative Complications in Elder Patients During Arthroscopic Shoulder Surgery in the Beach Chair Position
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.
Read the detailed description
To evaluate whether the use of non-invasive Hypotension Prediction Index-guided management reduces the duration and severity of intraoperative hypotension, as well as the incidence of intraoperative hypoxia and postoperative complications in patients undergoing arthroscopic shoulder surgery in the beach chair position.
The research team will include patients aged 65 to 90 years undergoing arthroscopic shoulder surgery in the beach chair position. Participants will be randomly assigned to either an HPI-guided group or a standard care group without HPI guidance. The duration and severity of intraoperative hypotension have been compared, as well as the incidence of postoperative complications between the two groups. Patients receiving HPI-guided management are expected to experience fewer and shorter episodes of intraoperative hypotension compared to those without HPI guidance.
- Being tested
- HPI, no HPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPIDevice
non-invasive HPI
no HPIDevice
no non-invasive HPI
| Study group | Role | What they receive |
|---|---|---|
| HPI | Other | HPI guidance of hemodynamic management Receives: Device: HPI |
| control | Other | no HPI guidance of hemodynamic management Receives: Device: no HPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of cerebral desaturation events
Measured: whole surgery
Secondary outcomes (1)
the time weighted average mean arterial pressure less than 65 mmHg
Measured: whole surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start27 Apr 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Intraoperative HypotensionnStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- HPI
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554599
- Sponsor's protocol ID
- 202509032RIND
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Non-Invasive Hypotension Prediction Index on Intraoperative Hypotension and Postoperative Complications in Elder Patients During Arthroscopic Shoulder Surgery in the Beach Chair Position
- ClinicalTrials.gov ID
- NCT07554599
- Acronym / sponsor ID
- 202509032RIND
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 28 Apr 2026 (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.
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.
Detailed description
To evaluate whether the use of non-invasive Hypotension Prediction Index-guided management reduces the duration and severity of intraoperative hypotension, as well as the incidence of intraoperative hypoxia and postoperative complications in patients undergoing arthroscopic shoulder surgery in the beach chair position.
The research team will include patients aged 65 to 90 years undergoing arthroscopic shoulder surgery in the beach chair position. Participants will be randomly assigned to either an HPI-guided group or a standard care group without HPI guidance. The duration and severity of intraoperative hypotension have been compared, as well as the incidence of postoperative complications between the two groups. Patients receiving HPI-guided management are expected to experience fewer and shorter episodes of intraoperative hypotension compared to those without HPI guidance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- HPI
| Arm | Type | Receives |
|---|---|---|
| HPI | Other | Device: HPIHPI guidance of hemodynamic management |
| control | Other | Device: no HPIno HPI guidance of hemodynamic management |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Non-emergent shoulder arthroscopy performed in the beach chair position, with eligibility criteria including male or female patients aged 65-90 years.
Key exclusion criteria (5 listed)
- Women who are pregnant, planning to become pregnant during the study period, or breastfeeding
- Individuals with major cardiac diseases, such as severe arrhythmia or heart failure
- Individuals with significant renal disease, e.g., chronic renal failure requiring dialysis
- Individuals with a history of stroke
- Individuals diagnosed with dementia
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 |
|---|---|---|
| HPInon-invasive HPI | Device | HPI |
| no HPIno non-invasive HPI | Device | control |
Primary outcome
the incidence of cerebral desaturation events
Time frame: whole surgery
1 secondary outcome
the time weighted average mean arterial pressure less than 65 mmHg
Time frame: whole surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. due to ethical issue
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.
Questions about this trial
What is this clinical trial studying?
A study testing HPI and no HPI in people with the Intraoperative Hypotensionn and the Brain Exygenation, run by National Taiwan University Hospital.
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 1 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: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Jun Lai (0972652086, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of cerebral desaturation events (time frame: whole surgery). 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 8 May 2026.