Perioperative Heart Rate Variability Analysis in Realtime

Completed

• Conditions: Heart Rate and Rhythm Disorders; Surgical Complications From General Anesthesia; Perioperative/Postoperative Complications; Individuality

• Registration Number: NCT02761031
• Lead Sponsor: Medical University of Vienna

Brief Summary

This study will record patient electrocardiograms - as well as various other body signals (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored routinely both during and immediately subsequent to surgical operations performed under general anesthesia. Through retrospective analysis of patients' heart rate variability (HRV), in concert with the other abovementioned parameters, the investigators seek to forward the development of novel mathematical models and tools for on-line detection of cardiovascular and autonomic dysfunction in the perioperative setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Primary Completion: 2018-05
• Status Verified: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Patients undergoing non-cardiac surgery under general anesthesia
• Patients aged 18-80 years
• Patients who are capable of giving informed consent

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Exclusion Criteria

• Patients <18 or >80 years of age
• Patients with an active cardiac pace maker
• Patients with an absent sinus rhythm in ECG
• Patients presenting with a preexisting arrhythmia
• Patients requiring postoperative ICU therapy
• Patients with pheochromocytoma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate variability	During and immediately subsequent to surgery performed under general anesthesia	The analysis of heart rate variability (HRV) has been used to assess autonomic nervous system responses to therapeutic interventions, and to quantify risk in a wide variety of both cardiac and non-cardiac disorders when combined with other diagnostic tests - though HRV analysis has seen its greatest cardiologic use in post-myocardial infarction risk stratification and in assessing risk for arrhythmic events. HRV analysis has become widespread and relatively simple to perform - however, until now, these analyses have not been performed in detail in the perioperative period.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Wien, Austria