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临床试验/NCT07621120
NCT07621120招募中不适用

Utilization of Wearable Accelerometer in Predicting of Perioperative Autonomic Function and Postoperative Complications in Elderly Patients

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年6月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang YuGuang

Professor

Peking Union Medical College Hospital

研究点 (1)

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