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临床试验/NCT03426501
NCT03426501已完成不适用

Association Between Heart Rate Variability and Perioperative and Long-term Mortality in Patients With Hip Fracture - an Observational Study

Vestre Viken Hospital Trust0 个研究点目标入组 165 人开始时间: 2008年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
165
主要终点
Number of Surviving patients six months after hip operation

研究概览

简要总结

165 patients admitted to two hospitals were included and short-time HRV measurements were obtained. Mortality data were gathered from the Norwegian central address register. Patients, close relatives of patients and in some cases their general physicians or nursery home physicians were interviewed six months postoperatively regarding the incidence of pneumonia, cardiac events or stroke.

详细描述

Patients with hip fractures admitted to Kongsberg hospital and o Oslo University Hospital between 2008 and 2013 were invited to participate in the study. Hemodynamically unstable patients, patients where it was impossible to obtain a 5 or 10-minute ECG signal (e.g. due to delirium), patients having undergone surgery the last month, cancer patients, patients with hip fractures due to high energy trauma, and patients considered moribund at admission, were excluded. A 5-10-minute ECG signal was recorded within 24 hours after arrival preoperatively and digitalized.

Heart rate was obtained by a Biocom 3000 ECG recorder (Kongsberg) and a Biocom 4000 ECG recorder (Oslo). The Biocom 3000 and 4000 ECG interface units use dry silver/ silver chloride ECG electrodes attached to the index fingers of the right and the left hand, respectively. Participants were asked to relax for 5 minutes. Afterwards, they were connected to the ECG, and a continuous ECG signal was obtained over 10 minutes (Kongsberg) or 5 minutes (Oslo). Linear parameters (time domain: SDNN, rMSSD; frequency domain: HF, LF, VLF, LF/HF) were calculated by a Heart Rhythm Scanner - Version 2.0 - (Biocom Technologies - U.S.A). Both signal measurement and processing was done according to international recommendations.

The investigators analysed HRV both in time domain and frequency domain. Time domain analysis measures the intervals between successive normal cardiac cycles. SDNN (the standard deviation of the NN intervals) reflects all the cyclic components responsible for variability in the period of recording and correlates strongly with total power (TP) of the frequency domain. rMSSD (root mean square successive difference) is calculated by drawing the square root of the mean value of the squared NN intervals. In healthy persons, the rMSSD value is 27 ± 12 ms. It estimates high-frequency variations in heart rate and correlates accordingly mostly with HF in the frequency domain. Changes in this parameter might show a decreased parasympathetic tone and discordance in sympathovagal activity.

Frequency domain (power spectral density) analysis describes the periodic oscillations of the heart rate signal, decomposed at different frequencies and amplitudes, and provides information on the amount of their relative intensity (termed variance of power) in the sinus rhythm of the heart. It is calculated with help of power spectral density by the fast Fourier transformation. Frequently reported indices are TP (total power), VLF (very low frequency power, < 0.003 -0.04 Hz), LF (low-frequency power, 0.04-0.15 Hz), HF (high-frequency power, 0.15-0.4 Hz), and the LF/HF ratio. It is recommended not to calculate VLF values from recordings lasting five minutes or less because VLF has a cycle period of 20 seconds to 5 minutes The measurement period should be at least twice as long as the cycle duration. The investigators therefore used only time series of 10 minutes (from the Kongsberg group) for calculation of VLF.

All ECGs were manually edited according to the Task force of the European Society of cardiology. If containing more than 30% pathological QRS-complexes, the patients' data were excluded.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hip fracture with indication of operative treatment.
  • Preoperative ECG
  • Preoperative CKMB and Troponin I

排除标准

  • Cardiocirculatoric unstable patient Atrial fibrillation
  • Agitated patient were it is unpossible to obtain a 10 minute ECG
  • Other operation in the last month
  • Cancer patients in an advanced stadium
  • Preterminal or terminal patients

结局指标

主要结局

Number of Surviving patients six months after hip operation

时间窗: 6 months etter inclusion

Mortality according to the Central Population Register

次要结局

  • Myocardial infarction(6 months etter inclusion)
  • Pneumonia(6 months etter inclusion)
  • Stroke(6 months etter inclusion)

研究者

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

Bente Wiik

Research consultant

Vestre Viken Hospital Trust

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