Post Induction HypotensionNCT07618416
Machine Learning Model Based on Baroreflex Sensitivity for Predicting Post-Induction Hypotension in Elderly Patients
An observational study of Post Induction Hypotension, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to develop a high-performance machine learning model combining dynamic baroreflex sensitivity (BRS) metrics and multi-dimensional static clinical features to predict the risk of post-induction hypotension (PIH) in elderly patients undergoing elective non-cardiac surgery under general… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Post Induction Hypotension
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients scheduled for elective operations
Who may be able to join
- Aged over 65 years;
- Scheduled for elective non-cardiac surgery;
- American Society of Anesthesiologists (ASA) physical status classification I-III;
- Planned for general anesthesia with endotracheal intubation;
- Patient and legal guardians are capable of understanding the study protocol and willing to provide written informed consent.
Who cannot join
- Severe peripheral vascular diseases;
- Secondary hypertension;
- Presence of physical tremors (e.g., Parkinson's disease) preventing stable recording;
- Inability to accurately measure upper limb blood pressure;
- Pre-existing cardiac arrhythmias (e.g., atrial fibrillation) that render BRS;
- Psychiatric disorders or cognitive impairments hindering basic cooperation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, China, 100730
Quexuan Cui, 13520921711, Cuiqx_garfield@126.com
About this study
Official title: Development of a Baroreflex Sensitivity-Based Multifactorial Machine Learning Model for Predicting Post-Induction Hypotension in Elderly Patients
The purpose of this study is to develop a high-performance machine learning model combining dynamic baroreflex sensitivity (BRS) metrics and multi-dimensional static clinical features to predict the risk of post-induction hypotension (PIH) in elderly patients undergoing elective non-cardiac surgery under general anesthesia.
Read the detailed description
Aging significantly alters cardiovascular autonomic function, characterized by elevated sympathetic and decreased parasympathetic tone, rendering elderly patients highly vulnerable to post-induction hypotension (PIH). While existing machine learning models heavily rely on static data (e.g., baseline blood pressure, demographics, medication history), they lack real-time dynamic regulatory inputs, limiting their predictive performance in individualized care.
This single-center, prospective cohort study aims to bridge this gap by introducing preoperative BRS parameters-calculated via the continuous non-invasive arterial pressure (CNAP) method-into machine learning frameworks. A total of 500 patients aged over 65 years scheduled for elective non-cardiac surgery will be enrolled. Preoperative data, including autonomic indices, frailty assessments, and static clinical factors, will be mapped alongside intraoperative events and 30-day postoperative complications. Multiple machine learning algorithms (Logistic Regression, Random Forest, GBDT, XGBoost, LightGBM, and LSTM) will be leveraged and optimized using cross-validation to construct a robust clinical decision-support pipeline.
- Conditions
- Post Induction Hypotension
- Keywords
- post-induction hypotension, elderly patient, baroreflex sensitivity, machine learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Surgical Patients | Patients aged over 65 years who are undergoing elective non-cardiac surgery under general anesthesia with endotracheal intubation. All patients will receive continuous non-invasive hemodynamic monitoring prior to anesthesia induction to calculate baseline BRS parameters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Induction Hypotension (PIH)
Defined as a systolic blood pressure (SBP) <90 mmHg , a mean arterial pressure (MAP) <65 mmHg, or a decrease in MAP exceeding 30% from baseline measurements.
Measured: From immediately after anesthesia induction up to 20 minutes post-induction or before surgical incision.
Secondary outcomes (2)
1. Early Intraoperative Hypotension Rate
Defined as a systolic blood pressure (SBP) <90 mmHg , a mean arterial pressure (MAP) <65 mmHg, or a decrease in MAP exceeding 30% from baseline measurements.
Measured: From surgical incision to the end of the operation.
Postoperative Complication
Measured: Up to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Induction HypotensionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang YuGuang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618416
- Sponsor's protocol ID
- 2025-PUMCH-A-119
- Other IDs
- 2025-PUMCH-A-119
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Baroreflex Sensitivity-Based Multifactorial Machine Learning Model for Predicting Post-Induction Hypotension in Elderly Patients
- ClinicalTrials.gov ID
- NCT07618416
- Acronym / sponsor ID
- 2025-PUMCH-A-119
- Conditions
- Post Induction Hypotension
- Keywords
- post-induction hypotension, elderly patient, baroreflex sensitivity, machine learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jun 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.
The purpose of this study is to develop a high-performance machine learning model combining dynamic baroreflex sensitivity (BRS) metrics and multi-dimensional static clinical features to predict the risk of post-induction hypotension (PIH) in elderly patients undergoing elective non-cardiac surgery under general anesthesia.
Detailed description
Aging significantly alters cardiovascular autonomic function, characterized by elevated sympathetic and decreased parasympathetic tone, rendering elderly patients highly vulnerable to post-induction hypotension (PIH). While existing machine learning models heavily rely on static data (e.g., baseline blood pressure, demographics, medication history), they lack real-time dynamic regulatory inputs, limiting their predictive performance in individualized care.
This single-center, prospective cohort study aims to bridge this gap by introducing preoperative BRS parameters-calculated via the continuous non-invasive arterial pressure (CNAP) method-into machine learning frameworks. A total of 500 patients aged over 65 years scheduled for elective non-cardiac surgery will be enrolled. Preoperative data, including autonomic indices, frailty assessments, and static clinical factors, will be mapped alongside intraoperative events and 30-day postoperative complications. Multiple machine learning algorithms (Logistic Regression, Random Forest, GBDT, XGBoost, LightGBM, and LSTM) will be leveraged and optimized using cross-validation to construct a robust clinical decision-support pipeline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Surgical Patients | – | –Patients aged over 65 years who are undergoing elective non-cardiac surgery under general anesthesia with endotracheal intubation. All patients will receive continuous non-invasive hemodynamic monitoring prior to anesthesia induction to calculate baseline BRS parameters. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients scheduled for elective operations
Key inclusion criteria (5 listed)
- Aged over 65 years;
- Scheduled for elective non-cardiac surgery;
- American Society of Anesthesiologists (ASA) physical status classification I-III;
- Planned for general anesthesia with endotracheal intubation;
- Patient and legal guardians are capable of understanding the study protocol and willing to provide written informed consent.
Key exclusion criteria (6 listed)
- Severe peripheral vascular diseases;
- Secondary hypertension;
- Presence of physical tremors (e.g., Parkinson's disease) preventing stable recording;
- Inability to accurately measure upper limb blood pressure;
- Pre-existing cardiac arrhythmias (e.g., atrial fibrillation) that render BRS;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Post-Induction Hypotension (PIH)
Time frame: From immediately after anesthesia induction up to 20 minutes post-induction or before surgical incision.
Defined as a systolic blood pressure (SBP) <90 mmHg , a mean arterial pressure (MAP) <65 mmHg, or a decrease in MAP exceeding 30% from baseline measurements.
2 secondary outcomes
1. Early Intraoperative Hypotension Rate
Time frame: From surgical incision to the end of the operation.
Postoperative Complication
Time frame: Up to 30 days post-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 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Induction Hypotension, run by Peking Union Medical College Hospital at 1 site in China.
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 6 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: looking for participants now, as of the sponsor's last update on 1 Jun 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 China. 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?
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 Quexuan Cui, Dr. (+8613520921711, Cuiqx_garfield@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-Induction Hypotension (PIH) (time frame: From immediately after anesthesia induction up to 20 minutes post-induction or before surgical incision.). 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 1 Jun 2026.