Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery (PreANI)

May 24, 2024 updated by: Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing major surgery within a multimodal rehabilitation program in various hospitals in Spain.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Patients who do not undergo prehabilitation.
Device: Analgesia Nociception Index (ANI) Monitor
Non-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu).
Prehabilitation
Patients who undergo trimodal prehabilitation including physical exercise, nutritional supplementation, and psychological support.
Device: Analgesia Nociception Index (ANI) Monitor
Non-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu).
Behavioral: Trimodal Prehabilitation
Program of physical exercise, nutritional supplementation, and psychological support according to the RICA guidelines of the Spanish Group for Multimodal Rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From initial pre-anesthesia consultation to 30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of postoperative complications
Time Frame: 30 days postoperatively
Evaluation of the relationship between higher preoperative functional reserve and lower number of complications, mortality, and hospital stay at 30 days postoperatively.
30 days postoperatively
Intraoperative decisions based on HRV
Time Frame: During the perioperative period
Analysis of whether HRV monitoring guides the workload during prehabilitation and the titration of drugs during surgery.
During the perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

Investigators

  • Study Chair: Cristian Aragón-Benedí, M.D., Ph.D.,, Miguel Servet University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PreANI001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share individual participant data (IPD) with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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