Perioperative Heart Rate Variability Analysis in Realtime

Perioperative/Postoperative Complications Clinical Trial

— PHERVR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761031
• Other study ID #: 2095/2015
• Status: Completed
• Start date: April 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna	Wien

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Vienna University of Technology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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