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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02375412

Enrollment

Registered

2015-03-02

Start date

2015-02-28

Completion date

2017-03-31

Last updated

2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Abdominal Surgery

Keywords

heart rate variability, post-operative outcome

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.

Interventions

PROCEDUREPre-operative measurement of heart rate variability

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pre-defined postoperative complications for up to 28 days after surgery	24 months	The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.

Secondary

Measure	Time frame	Description
The length of hospitalization	24 months	Length of hospital stay will be obtained from the patient record.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026