The Predictive Value of Heart Rate Variability for the Prognosis of Patients With Mild to Moderate Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Glasgow Outcome Score
研究概览
简要总结
This study adopts a retrospective design, continuously including patients with TBI treated at the Emergency Trauma Center of the First Affiliated Hospital of Suzhou University from May 2017 to September 2024. Investigators used the hospital's electronic medical record system to collect clinical data. The patients' age, gender, history of diabetes, history of hypertension, medication history, mechanism of injury, mean arterial pressure, Glasgow Coma Scale, and other information were recorded upon emergency admission. Laboratory indicators included white blood cell count, hemoglobin (HB) levels, platelet count, C-reactive protein, international normalized ratio (INR), and albumin. Myocardial injury markers included alpha-hydroxybutyrate dehydrogenase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, creatine kinase-MB (CK-MB), myoglobin, NT-pro BNP, and high-sensitivity troponin T. Additionally, continuous ECG monitoring was conducted for 24 hours after admission.
详细描述
This study adopts a retrospective design, continuously including patients with TBI treated at the Emergency Trauma Center of the First Affiliated Hospital of Suzhou University from May 2017 to September 2024. Investigators used the hospital's electronic medical record system to collect clinical data. The patients' age, gender, history of diabetes, history of hypertension, medication history, mechanism of injury, mean arterial pressure, Glasgow Coma Scale, and other information were recorded upon emergency admission. Laboratory indicators included white blood cell count, hemoglobin (HB) levels, platelet count, C-reactive protein, international normalized ratio (INR), and albumin. Myocardial injury markers included alpha-hydroxybutyrate dehydrogenase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, creatine kinase-MB (CK-MB), myoglobin, NT-pro BNP, and high-sensitivity troponin T. Additionally, continuous ECG monitoring was conducted for 24 hours after admission.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of traumatic brain injury
- •GCS score between 9-15;
- •Head and neck simplified injury score (AIS) ≤4;
排除标准
- •clinical diagnosis of tumors, active infections, or hematologic diseases;
- •those who have received treatment with beta-blockers, anticholinergic drugs, or anticoagulants within 6 months before admission;
结局指标
主要结局
Glasgow Outcome Score
时间窗: 6 months after discharge
Glasgow Outcome Score 1. Dead: As a direct result of brain trauma, or due to secondary complications, or other complications 2. Vegetative State: Patients who remain unresponsive and speechless.... 3， Severe Disability: The patient is conscious but needs the assistance of another person for some activities of daily living every day 4， Moderate Disability: Such a patient can look after himself at home, get out and about to the shops, and travel by public transport. However, some previous activities, either at work or in social life, are now no longer possible because of either physical or mental deficit 5， Good Recovery: This indicates the capacity to resume normal occupational and social activities, although minor physical or mental deficits may exist. Social outcomes should be included in the assessment here, such as leisure activities and family relationships.
Standard deviation of all NN intervals（SDNN）
时间窗: Day 1 post-TBI.
This metric measures the standard deviation of normal beat-to-beat intervals (SDNN) present within the heart rhythm. It is a time domain measure of heart rate variability（HRV）, and it serves as a marker of overall adaptability of the nervous system.
The average of all 5-minute standard deviations of NN intervals across a 24-hour period (SDNN index)
时间窗: day 1 post TBI
The average of all 5-minute standard deviations of NN intervals across 24 hours (SDNN index). Reflects combined parasympathetic and sympathetic modulation
The root mean square of successive differences between NN intervals (RMSSD)
时间窗: Day 1 post-TBI
The Root Mean Square of Successive Differences between NN intervals (RMSSD) quantifies the variability in time intervals between consecutive normal heartbeats (NN intervals) on an electrocardiogram (ECG). Reflects parasympathetic (vagal) tone, as it captures rapid, beat-to-beat changes in heart rate mediated by the autonomic nervous system. A higher RMSSD indicates greater HRV and adaptability of the cardiovascular system, often associated with better stress resilience and recovery.
The proportion of consecutive NN intervals differing by over 50 ms, relative to the total number of NN intervals (pNN50)
时间窗: day 1 post-TBI
A higher pNN50 indicates greater parasympathetic dominance. A lower pNN50 suggests reduced vagal tone, common in stress, aging, or pathologies.
Triangle index
时间窗: day 1 post TBI
The Triangle Index is a global measure of heart rate variability derived from the geometric properties of an NN interval histogram. A higher value indicates greater overall HRV, reflecting healthy autonomic nervous system function.
HRV High Frequency Power
时间窗: Day 1 post-TBI
Baseline level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded on day 1 of TBI
HRV low frequency power
时间窗: Day 1 post- TBI
Low-frequency (LF) power (typically 0.04-0.15 Hz) is a spectral component of HRV reflecting mixed sympathetic and parasympathetic influences on heart rate, with potential contributions from baroreflex activity.
HRV very low frequency power
时间窗: Day 1 post- TBI
VLF (Very-Low-Frequency) power is a spectral component of heart rate variability (HRV) in the 0.0033-0.04 Hz range (or sometimes \<0.05 Hz). VLF is linked to long-term autonomic and neurohormonal control.
次要结局
- Creatine Kinase-MB(On Day 1 after TBI onset)
- Myoglobin(On Day 1 after TBI onset)
- Glasgow Coma Scale(On Day 1 after TBI onset)
- Hypertension history(On Day 1 after TBI onset)
- Diabetes history(On Day 1 after TBI onset)
- Age(Baseline)
- White Blood Cell Count(On Day 1 after TBI onset)
- Hemoglobin(On Day 1 after TBI onset)
- Platelets (thrombocytes)(On Day 1 after TBI onset)
- C-Reactive Protein (CRP)(On Day 1 after TBI onset)
- International Normalized Ratio(On Day 1 after TBI onset)
- Albumin(On Day 1 after TBI onset)
- Alpha-Hydroxybutyrate Dehydrogenase(On Day 1 after TBI onset)
- Creatine Kinase(On Day 1 after TBI onset)
- Lactate Dehydrogenase(On Day 1 after TBI onset)
- Aspartate Aminotransferase(On Day 1 after TBI onset)
- N-Terminal pro-BNP(On Day 1 after TBI onset)
- High-Sensitivity Troponin T(On Day 1 after TBI onset)
研究者
Peng Yang
phd.
The First Affiliated Hospital of Soochow University