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Completed

NCT Number: NCT02375412

Preoperative Measurement of Heart Rate Variability as a Predictor of Postoperative Outcome

The purpose of the study is to confirm the hypothesis that a dysfunction of the autonomic nervous system could complicate the postoperative course in the patient undergoing surgery. Measurement of heart rate variability (HRV) is a non-invasive method for evaluation of the autonomic nervous system.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ostrava

Ostrava-Poruba, Czech Republic, 708 52, Czechia

About this study

The autonomic nervous system (ANS) plays an important role in the maintenance of systemic homeostasis. The homeostasis is modified continually by internal and external stimuli to which the autonomic nervous system modulates the response of organism by tight control on essential functions such as circulation, respiration, hormonal secretion and thermoregulation. Dysfunction of the autonomic nervous system could complicate the perioperative course in the patient undergoing surgery; therefore it should be considered as another risk factor during preoperative evaluation. Nowadays the evaluation of the autonomic nervous system function like a tool for prediction postoperative outcome is not considered in daily anaesthesiology practice. Measurement of heart rate variability (HRV) is a method for evaluation the autonomic nervous system function. It is a non-invasive method that provides information about the autonomic regulation of organism and thus it identifies patients with the autonomic nervous system dysfunction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 21 years of age and above
  • anticipated duration of surgery more than 120 minutes
  • estimated blood loss exceeding more than 15% of blood volume
  • American Society of Anesthesiology (ASA) classification 2 or 3

Exclusion criteria

  • pregnant or lactating women
  • age below 21 years of age
  • emergency surgery
  • American Society of Anesthesiology (ASA) classification 1
  • sepsis and septic shock
  • severe cardiac arrhythmias

Treatment and study plan

Pre-operative measurement of heart rate variability

Procedure

Pre-operative measurement of heart rate variability in patients undergoing elective major abdominal surgery

Primary outcomes

  1. Pre-defined postoperative complications for up to 28 days after surgery

    Time frame: 24 months

    The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.

Secondary outcomes

  1. The length of hospitalization

    Time frame: 24 months

    Length of hospital stay will be obtained from the patient record.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

Preoperative Evaluation of Autonomic Nervous System by Heart Rate Variability as a Predictor of Postoperative Outcome in the Patient Undergoing Major Elective Abdominal Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 2, 2015
Registry last updated
Mar 8, 2017

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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