Perioperative Heart Rate Variability Analysis in Realtime

NCT02761031 | Completed

• 1 other identifier: 2095/2015
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Heart rate variability; Electrocardiography; Observational study; Non-interventional study; Risk assessment; Perioperative

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Vienna University of Technology: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam J Bukaty, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Ulrich Klein, MD, PD

  Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Adam Joel Bukaty

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

AU (1)