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NCT02375412 Clinical Trial

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

Major Abdominal Surgery Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02375412
Other study ID # FNO-KARIM-2
Secondary ID
Status Completed
Phase N/A
First received February 24, 2015
Last updated March 7, 2017
Start date February 2015
Est. completion date March 2017

Study information
Verified date March 2017
Source University Hospital Ostrava
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 21 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Czech Republic University Hospital Ostrava Ostrava-Poruba

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czech Republic, 

References & Publications (3)

Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. — View Citation

Laitio T, Jalonen J, Kuusela T, Scheinin H. The role of heart rate variability in risk stratification for adverse postoperative cardiac events. Anesth Analg. 2007 Dec;105(6):1548-60. Review. — View Citation

Mazzeo AT, La Monaca E, Di Leo R, Vita G, Santamaria LB. Heart rate variability: a diagnostic and prognostic tool in anesthesia and intensive care. Acta Anaesthesiol Scand. 2011 Aug;55(7):797-811. doi: 10.1111/j.1399-6576.2011.02466.x. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pre-defined postoperative complications for up to 28 days after surgery The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death. 24 months
Secondary The length of hospitalization Length of hospital stay will be obtained from the patient record. 24 months
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