Post Induction HypotensionNCT07621120
Wearable Accelerometers for Predicting Perioperative Risk in Elderly Patients
An observational study of Post Induction Hypotension, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This single-center prospective cohort study is designed to evaluate whether preoperative physical activity measured by a wearable accelerometer is associated with cardiovascular autonomic function and whether it can help predict post-induction hypotension in elderly patients undergoing elective non-cardiac surgery. 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 31 Dec 2027
- How long will I take part?
- 3 Months
- 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: Elderly patients who will undergo general anesthesia surgery in Peking Union Medical College Hospital.
Who may be able to join
- Age ≥65 years
- Scheduled for elective non-cardiac surgery
- American Society of Anesthesiologists (ASA) physical status I-III
- Planned to undergo general anesthesia
- Planned tracheal intubation
- The patient and family members are able to understand the study protocol, are willing to participate, and provide written informed consent
Who cannot join
- Severe vascular disease
- Secondary hypertension
- Limb tremor disorders, such as Parkinson disease
- Inability to wear a wrist-based wearable accelerometer for any reason
- Inability to measure upper-extremity blood pressure
- Atrial fibrillation or other arrhythmias unsuitable for baroreflex sensitivity measurement
- Mental or psychiatric conditions resulting in inability to cooperate with study procedures
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, Beijing Municipality, 100730
Quexuan Cui, 008613520921711, Cuiqx_garfield@126.com
About this study
Official title: Utilization of Wearable Accelerometer in Predicting of Perioperative Autonomic Function and Postoperative Complications in Elderly Patients
This single-center prospective cohort study is designed to evaluate whether preoperative physical activity measured by a wearable accelerometer is associated with cardiovascular autonomic function and whether it can help predict post-induction hypotension in elderly patients undergoing elective non-cardiac surgery. Patients aged 65 years or older scheduled for general anesthesia with tracheal intubation will undergo preoperative physical activity monitoring using an ActiGraph wearable accelerometer. Activity-related parameters, including sedentary time, light-, moderate-, and vigorous-intensity activity, daily step count, and sleep duration, will be recorded. Cardiovascular autonomic function will be assessed perioperatively using noninvasive continuous hemodynamic monitoring, with baroreflex sensitivity-related indices derived from continuous blood pressure and beat-to-beat timing data. The primary outcome is post-induction hypotension. Secondary outcomes include early intraoperative hypotension, postoperative complications, and 30-day mortality. This study aims to clarify the relationship between habitual physical activity and autonomic regulation in older surgical patients and to provide evidence supporting future prehabilitation strategies.
Read the detailed description
Older adults undergoing surgery are at increased risk of perioperative hemodynamic instability and postoperative complications. Aging is associated with changes in cardiovascular autonomic regulation, including increased sympathetic activity and reduced parasympathetic tone. Perioperative autonomic dysfunction has been associated with adverse outcomes such as intraoperative hypotension, postoperative pain, postoperative nausea and vomiting, and impaired postoperative recovery. Baroreflex sensitivity is an important quantitative indicator of cardiovascular autonomic function and reflects the heart rate response to changes in blood pressure. Impaired baroreflex function in elderly patients may contribute to a higher risk of post-induction hypotension and other adverse perioperative outcomes.
Physical activity has been shown to be associated with autonomic regulation, and exercise-based interventions may improve baroreflex sensitivity. However, the relationship between preoperative habitual physical activity and baseline autonomic function in elderly surgical patients has not been well defined. Wearable accelerometers provide an objective means of quantifying daily activity and may offer additional value beyond conventional self-reported functional assessments. This study therefore hypothesizes that preoperative physical activity level is associated with baseline cardiovascular autonomic function in elderly patients and that accelerometer-derived activity metrics may be useful in predicting post-induction hypotension and other perioperative outcomes.
This study is a single-center, prospective observational cohort study. Eligible participants will be patients aged 65 years or older, classified as ASA physical status I to III, and scheduled for elective non-cardiac surgery under general anesthesia with tracheal intubation. Major exclusion criteria include severe vascular disease, secondary hypertension, limb tremor disorders such as Parkinson disease, inability to wear a wrist-based accelerometer, inability to measure upper-extremity blood pressure, arrhythmias unsuitable for baroreflex sensitivity measurement, and inability to cooperate with study procedures. Written informed consent will be obtained from all participants or their family members as required.
Before surgery, participants will undergo collection of baseline clinical information, including comorbidities, current medications, and routine preoperative test results. Physical activity and frailty will also be assessed using the short-form International Physical Activity Questionnaire, the FRAIL scale, and the Fried frailty scale. After enrollment, participants will wear an ActiGraph wGT3X-BT accelerometer to continuously record daily physical activity and sleep-related parameters before surgery, including sedentary time, time spent in light-, moderate-, and vigorous-intensity activity, daily step count, and sleep duration.
Perioperative hemodynamic monitoring will include preoperative noninvasive continuous arterial pressure monitoring using the LiDCO rapid V3 system. Under standardized resting conditions, continuous blood pressure and beat-to-beat cardiovascular data will be collected for baroreflex sensitivity analysis. Deep slow breathing testing will also be performed. Preoperative volume-related variables, including time since last fluid intake, intravenous fluid administration, and passive leg raising response assessed by stroke volume change, will be recorded.
During surgery, routine intraoperative monitoring will include pulse oximetry, electrocardiography, and noninvasive blood pressure measurement every 3 minutes. Hemodynamic data at baseline, after induction, and at major intraoperative events will be recorded. Detailed information regarding anesthetic induction and maintenance, including sedative, analgesic, neuromuscular blocking, and vasoactive medications, will also be collected. Postoperative follow-up will be performed on postoperative days 1, 3, and 7 to assess complications according to the Clavien-Dindo classification, postoperative examinations, and quality of recovery using the QoR-15 questionnaire. A 30-day telephone follow-up will be conducted to assess postoperative complications, metabolic equivalent status, and other relevant events.
The primary outcome is post-induction hypotension, defined as systolic blood pressure less than 90 mmHg, mean arterial pressure less than 65 mmHg, or a decrease of more than 30% from baseline within 20 minutes after induction of anesthesia or before surgical incision. Secondary outcomes include the incidence of early intraoperative hypotension, postoperative complications graded by the Clavien-Dindo classification, and all-cause mortality within 30 days after surgery. The planned sample size is 100 patients. Statistical analyses will evaluate associations between preoperative physical activity variables and post-induction hypotension, with adjustment for potential confounding factors such as induction regimen and baseline blood pressure using logistic regression models.
- Conditions
- Post Induction Hypotension
- Keywords
- post induction hypotension, elderly patient, wearable accelerometer
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 |
|---|---|---|
| observational group | all of enrolled patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post induction hypotension
Systolic blood pressure less than 90 mmHg, mean arterial pressure less than 65 mmHg, or a decrease of more than 30% from baseline.
Measured: Within 20 minutes after induction of anesthesia or before surgical incision.
Early intraoperative hypotension
Systolic blood pressure less than 90 mmHg, mean arterial pressure less than 65 mmHg, or a decrease of more than 30% from baseline.
Measured: Within 30 minutes after incision
Secondary outcomes (1)
Postoperative complications
We use Clavien-Dindo system to grade postoperative complications
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 100 participants (estimated)
- Target duration
- 3 Months
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
- NCT07621120
- Sponsor's protocol ID
- PUMCHAIIT-2025-09
- Status last verified
- Apr 2026
- First submitted
- 25 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team is currently evaluating whether de-identified individual participant data can be shared after study completion and publication, subject to institutional policy, ethics requirements, and data access procedures.
Publications
Finet M, Bellicha A, Sage E, Glorion M, Kennel T, Labro M, Trillat B, Fischler M, Vallee A, Le Guen M, Fessler J. Comprehensive assessment of postoperative mobility during the first days after mini-invasive lung surgery: A prospective observational study. J Clin Anesth. 2023 Jun;86:111048. doi: 10.1016/j.jclinane.2022.111048. Epub 2023 Jan 28.
PubMed 36716650Gardenghi G, Rondon MU, Braga AM, Scanavacca MI, Negrao CE, Sosa E, Hachul DT. The effects of exercise training on arterial baroreflex sensitivity in neurally mediated syncope patients. Eur Heart J. 2007 Nov;28(22):2749-55. doi: 10.1093/eurheartj/ehm208. Epub 2007 Jun 7.
PubMed 17561494
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Wearable Accelerometer in Predicting of Perioperative Autonomic Function and Postoperative Complications in Elderly Patients
- ClinicalTrials.gov ID
- NCT07621120
- Acronym / sponsor ID
- PUMCHAIIT-2025-09
- Conditions
- Post Induction Hypotension
- Keywords
- post induction hypotension, elderly patient, wearable accelerometer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 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.
This single-center prospective cohort study is designed to evaluate whether preoperative physical activity measured by a wearable accelerometer is associated with cardiovascular autonomic function and whether it can help predict post-induction hypotension in elderly patients undergoing elective non-cardiac surgery. Patients aged 65 years or older scheduled for general anesthesia with tracheal intubation will undergo preoperative physical activity monitoring using an ActiGraph wearable accelerometer. Activity-related parameters, including sedentary time, light-, moderate-, and vigorous-intensity activity, daily step count, and sleep duration, will be recorded. Cardiovascular autonomic function will be assessed perioperatively using noninvasive continuous hemodynamic monitoring, with baroreflex sensitivity-related indices derived from continuous blood pressure and beat-to-beat timing data. The primary outcome is post-induction hypotension. Secondary outcomes include early intraoperative hypotension, postoperative complications, and 30-day mortality. This study aims to clarify the relationship between habitual physical activity and autonomic regulation in older surgical patients and to provide evidence supporting future prehabilitation strategies.
Detailed description
Older adults undergoing surgery are at increased risk of perioperative hemodynamic instability and postoperative complications. Aging is associated with changes in cardiovascular autonomic regulation, including increased sympathetic activity and reduced parasympathetic tone. Perioperative autonomic dysfunction has been associated with adverse outcomes such as intraoperative hypotension, postoperative pain, postoperative nausea and vomiting, and impaired postoperative recovery. Baroreflex sensitivity is an important quantitative indicator of cardiovascular autonomic function and reflects the heart rate response to changes in blood pressure. Impaired baroreflex function in elderly patients may contribute to a higher risk of post-induction hypotension and other adverse perioperative outcomes.
Physical activity has been shown to be associated with autonomic regulation, and exercise-based interventions may improve baroreflex sensitivity. However, the relationship between preoperative habitual physical activity and baseline autonomic function in elderly surgical patients has not been well defined. Wearable accelerometers provide an objective means of quantifying daily activity and may offer additional value beyond conventional self-reported functional assessments. This study therefore hypothesizes that preoperative physical activity level is associated with baseline cardiovascular autonomic function in elderly patients and that accelerometer-derived activity metrics may be useful in predicting post-induction hypotension and other perioperative outcomes.
This study is a single-center, prospective observational cohort study. Eligible participants will be patients aged 65 years or older, classified as ASA physical status I to III, and scheduled for elective non-cardiac surgery under general anesthesia with tracheal intubation. Major exclusion criteria include severe vascular disease, secondary hypertension, limb tremor disorders such as Parkinson disease, inability to wear a wrist-based accelerometer, inability to measure upper-extremity blood pressure, arrhythmias unsuitable for baroreflex sensitivity measurement, and inability to cooperate with study procedures. Written informed consent will be obtained from all participants or their family members as required.
Before surgery, participants will undergo collection of baseline clinical information, including comorbidities, current medications, and routine preoperative test results. Physical activity and frailty will also be assessed using the short-form International Physical Activity Questionnaire, the FRAIL scale, and the Fried frailty scale. After enrollment, participants will wear an ActiGraph wGT3X-BT accelerometer to continuously record daily physical activity and sleep-related parameters before surgery, including sedentary time, time spent in light-, moderate-, and vigorous-intensity activity, daily step count, and sleep duration.
Perioperative hemodynamic monitoring will include preoperative noninvasive continuous arterial pressure monitoring using the LiDCO rapid V3 system. Under standardized resting conditions, continuous blood pressure and beat-to-beat cardiovascular data will be collected for baroreflex sensitivity analysis. Deep slow breathing testing will also be performed. Preoperative volume-related variables, including time since last fluid intake, intravenous fluid administration, and passive leg raising response assessed by stroke volume change, will be recorded.
During surgery, routine intraoperative monitoring will include pulse oximetry, electrocardiography, and noninvasive blood pressure measurement every 3 minutes. Hemodynamic data at baseline, after induction, and at major intraoperative events will be recorded. Detailed information regarding anesthetic induction and maintenance, including sedative, analgesic, neuromuscular blocking, and vasoactive medications, will also be collected. Postoperative follow-up will be performed on postoperative days 1, 3, and 7 to assess complications according to the Clavien-Dindo classification, postoperative examinations, and quality of recovery using the QoR-15 questionnaire. A 30-day telephone follow-up will be conducted to assess postoperative complications, metabolic equivalent status, and other relevant events.
The primary outcome is post-induction hypotension, defined as systolic blood pressure less than 90 mmHg, mean arterial pressure less than 65 mmHg, or a decrease of more than 30% from baseline within 20 minutes after induction of anesthesia or before surgical incision. Secondary outcomes include the incidence of early intraoperative hypotension, postoperative complications graded by the Clavien-Dindo classification, and all-cause mortality within 30 days after surgery. The planned sample size is 100 patients. Statistical analyses will evaluate associations between preoperative physical activity variables and post-induction hypotension, with adjustment for potential confounding factors such as induction regimen and baseline blood pressure using logistic regression models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group | – | –all of enrolled patients |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients who will undergo general anesthesia surgery in Peking Union Medical College Hospital.
Key inclusion criteria (6 listed)
- Age ≥65 years
- Scheduled for elective non-cardiac surgery
- American Society of Anesthesiologists (ASA) physical status I-III
- Planned to undergo general anesthesia
- Planned tracheal intubation
Key exclusion criteria (7 listed)
- Severe vascular disease
- Secondary hypertension
- Limb tremor disorders, such as Parkinson disease
- Inability to wear a wrist-based wearable accelerometer for any reason
- Inability to measure upper-extremity blood pressure
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
Post induction hypotension
Time frame: Within 20 minutes after induction of anesthesia or before surgical incision.
Systolic blood pressure less than 90 mmHg, mean arterial pressure less than 65 mmHg, or a decrease of more than 30% from baseline.
Early intraoperative hypotension
Time frame: Within 30 minutes after incision
Systolic blood pressure less than 90 mmHg, mean arterial pressure less than 65 mmHg, or a decrease of more than 30% from baseline.
1 secondary outcome
Postoperative complications
Time frame: Within 30 days after 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 2 Jun 2026.
- Background: PubMed 36716650Finet M, Bellicha A, Sage E, Glorion M, Kennel T, Labro M, Trillat B, Fischler M, Vallee A, Le Guen M, Fessler J. Comprehensive assessment of postoperative mobility during the first days after mini-invasive lung surgery: A prospective observational study. J Clin Anesth. 2023 Jun;86:111048. doi: 10.1016/j.jclinane.2022.111048. Epub 2023 Jan 28.
- Background: PubMed 17561494Gardenghi G, Rondon MU, Braga AM, Scanavacca MI, Negrao CE, Sosa E, Hachul DT. The effects of exercise training on arterial baroreflex sensitivity in neurally mediated syncope patients. Eur Heart J. 2007 Nov;28(22):2749-55. doi: 10.1093/eurheartj/ehm208. Epub 2007 Jun 7.
- Individual participant dataSharing planned: Undecided. The study team is currently evaluating whether de-identified individual participant data can be shared after study completion and publication, subject to institutional policy, ethics requirements, and data access procedures.
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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 6 inclusion and 7 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 2 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 (13520921711, Cuiqx_garfield@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post induction hypotension (time frame: Within 20 minutes after induction of anesthesia or before surgical incision.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07621120, which also lists 2 linked publications.
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 2 Jun 2026.