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Clinical Trials/NCT02761031
NCT02761031CompletedNot Applicable

Perioperative Heart Rate Variability Analysis in Realtime: Detection of Cardiovascular and Autonomic Dysfunction

Medical University of Vienna1 site in 1 country88 target enrollmentStarted: April 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
88
Locations
1
Primary Endpoint
Heart rate variability

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

Heart rate variability

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adam Joel Bukaty

Dr. Adam Joel Bukaty

Medical University of Vienna

Study Sites (1)

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