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Clinical Trials/NCT02375412
NCT02375412
Completed
Not Applicable

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

University Hospital Ostrava1 site in 1 country65 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Abdominal Surgery
Sponsor
University Hospital Ostrava
Enrollment
65
Locations
1
Primary Endpoint
Pre-defined postoperative complications for up to 28 days after surgery
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
March 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Ostrava
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • The length of hospitalization(24 months)

Study Sites (1)

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