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临床试验/NCT06436417
NCT06436417招募中不适用

Monitoring Functional Capacity Through Heart Rate Variability Within the Multimodal Rehabilitation Program in Adult Surgery

Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
490
试验地点
1
主要终点
Correlation of HRV indices with functional capacity and frailty

研究概览

简要总结

This prospective, observational cohort study investigates heart rate variability (HRV) monitoring using the Analgesia Nociception Index (ANI) monitor in adult patients undergoing major surgery within a multimodal rehabilitation program. The objective is to correlate HRV indices with functional capacity, physiological reserve, and frailty during the prehabilitation phase.

详细描述

The study evaluates HRV using the ANI monitor to determine adaptation to training load, optimize analgesic and anesthetic dosing, and predict postoperative complications. The HRV indices of Energy (SDNN) and ANI (HFnu) are monitored at two points: the initial pre-anesthesia consultation and one week before surgery. Results will be compared with the 6-minute walk test, MUST nutrition screening scale, and clinical frailty and FRAIL scales.

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

  • Patients over 18 years of age
  • Scheduled for major adult surgery
  • Any ASA classification
  • Signed informed consent

排除标准

  • Urgent surgery
  • Severe cognitive impairment
  • Patient refusal to participate
  • Pediatric patients
  • Cardiac arrhythmia or atrial fibrillation

结局指标

主要结局

Correlation of HRV indices with functional capacity and frailty

时间窗: From initial pre-anesthesia consultation to 30 days postoperatively

Evaluation of the correlation between HRV indices (Energy and ANI) and current parameters used to assess functional capacity, physiological reserve, and frailty.

次要结局

  • Reduction of postoperative complications(30 days postoperatively)
  • Intraoperative decisions based on HRV(During the perioperative period)

研究者

发起方
Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
申办方类型
Network
责任方
Sponsor

研究点 (1)

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