Perioperative Heart Rate Variability Analysis in Realtime (PHERVR)

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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Austria
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients between the ages of 18 and 80 who are undergoing non-cardiac surgery under general anesthesia at Vienna General Hospital may participate.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	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.	During and immediately subsequent to surgery performed under general anesthesia

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Vienna University of Technology
• Investigators: Principal Investigator: Adam J Bukaty, MD, Medical University of Vienna; Study Director: Ulrich Klein, MD, PD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (ESTIMATE): May 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Perioperative; Non-interventional study; Observational study; Heart rate variability; Electrocardiography; Risk assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2095/2015