Heart Rate Variability at the Emergency Department

Heart Rate Variability Clinical Trial

Official title:

Heart Rate Variabitlity at the Emergency Department: a New Triage Parameter?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093439
• Other study ID #: BC-08267
• Secondary ID: B.U.N.: B6702020
• Status: Completed
• Start date: October 11, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: November 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study investigators want to examine if heart rate variability at hospital entry predicts prognosis in participants with severe disease.

Description:

Predictive parameters that can predict the outcome are very scarce. Vital parameters such as heart rate, blood pressure, saturation, etc. can be normal for a long time or only slightly changed, even in seriously ill patients. Heart rate variability is a parameter that can be used as a measure of autonomic dysfunction. Lower heart rate variability is associated with increased mortality and morbidity according to recent studies. Heart rate variability could thus be used to identify the need for intervention and treatment more quickly.

In this study, we want to investigate whether there is indeed a relationship between heart rate variability at admission to the emergency department and eventual mortality and morbidity in critically ill patients.

Therefore, heart rate variability will be determined in patients admitted to the emergency department who were triaged in red or orange according to the Manchester Triage System (internationally validated triage system that is also used in the emergency department at UZ Gent). Subanalyses will be made for patients with trauma, sepsis, pneumonia, CVA and acute myocardial infarction. Determination of heart rate variability will be done by EKG monitoring during the first 5 minutes and after 3 hours. There are several parameters that can reflect heart rate variability. Both frequency domain measurements and non-linair measurements will be determined. Use will be made of the Kubios programme, a free programme that can determine these different parameters on the basis of EKG monitoring. Patients who are resuscitated on arrival will be excluded, as well as patients in VKF, as the heart rate variability on arrival cannot be determined for these two groups. Demographic data (age, sex,...), history and home medication, vital parameters (heart rate, blood pressure, saturation, temperature, respiratory rate) and some lab data (lactate, CRP) will also be collected. The primary outcome will be mortality after 30 days. Secondary outcomes that will be studied are the total duration of hospital stay and the duration of stay in the intensive care unit, as well as the need for life-saving interventions (need for surgery, ventilation, inotropics, PCI or thrombolysis).

By collecting these data, we want to find out whether heart rate variability is a good predictor of outcome, and thus the need for ICU admission, faster invasive interventions,... During this study, the patient's management will remain unchanged.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with (possible) sepsis, myocardial infarction, cerebrovascular accident, polytrauma or Covid 19 pneumonia who were triaged red or orange following the Manchester triage system

Exclusion Criteria:

Patients with cardiac arrest or arrhythmia at arrival

Related Conditions & MeSH terms

• Emergencies
• Emergency Department
• Heart Rate Variability

Intervention

Diagnostic Test:
• Heart Rate Variability
Heart rate variability wil be calculated from patients' 10 sec ECG with a dedicated software (Kubios).

Locations

Country	Name	City	State
Belgium	University Hospital Ghent - Emergency Department	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality		30 days
Secondary	Length of Hospital Stay		0 - 100 days
Secondary	Length of stay at the intensive care unit		0 - 100 days
Secondary	Need for life threatening interventions	Need for surgery, mechanical ventilation, inotropic medications, PCI or thrombolysis	In 0 - 7 days after admission