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Clinical Trials/NCT06436417
NCT06436417
Recruiting
Not Applicable

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

Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon1 site in 1 country490 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty in Adult Surgery
Sponsor
Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
Enrollment
490
Locations
1
Primary Endpoint
Correlation of HRV indices with functional capacity and frailty
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
December 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Correlation of HRV indices with functional capacity and frailty

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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