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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Patients who do not undergo prehabilitation. |
| |
| Prehabilitation | Patients who undergo trimodal prehabilitation including physical exercise, nutritional supplementation, and psychological support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analgesia Nociception Index (ANI) Monitor | Device | Non-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu). |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of HRV indices with functional capacity and frailty | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of postoperative complications | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing major surgery within a multimodal rehabilitation program in various hospitals in Spain.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristian Aragón-Benedí, M.D., Ph.D., | Contact | +34625408866 | cristianaragon@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristian Aragón-Benedí, M.D., Ph.D., | Miguel Servet University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miguel Servet University Hospital | Recruiting | Zaragoza | 50009 | Spain |
There are no plans to share individual participant data (IPD) with other researchers.
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Trimodal Prehabilitation | Behavioral | Program of physical exercise, nutritional supplementation, and psychological support according to the RICA guidelines of the Spanish Group for Multimodal Rehabilitation. |
|
Analysis of whether HRV monitoring guides the workload during prehabilitation and the titration of drugs during surgery. |
| During the perioperative period |