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OpenTrials
Completed

NCT Number: NCT02761031

Perioperative Heart Rate Variability Analysis in Realtime

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.

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Key information

Conditions

Individuality Heart Rate and Rhythm Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Surgical Complications From General Anesthesia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Vienna University of Technology

Registry information

Official study title

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

Acronym: PHERVR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 4, 2016
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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