ST-T Segment Changes in Emergency Physicians While on Duty

NCT ID: NCT04003883

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-11-30

Brief Summary

Preclinical emergency management is frequently associated with a combination of physical and psychological stress.

This stress is known to lead to a broad variety of changes in the physiology even extending in the cardiovascular system. Both physical and psychological stress induces ECG changes. These changes include not only arrhythmias but also deviations in ST-T segment representing the phase of repolarization.

Information about changes in ST-T segment are missing until now. The investigators hypothesise that ST-T deviations occur in emergency physicians during shift at an emergency response car.

In order to show changes in ST-T segment a prospective observational trial will be conducted. By using a 12 lead ECG Holter the investigators will obtain ECGs during shifts of emergency physicians at an emergency response vehicle.

During 12-hour shifts emergency physicians will be attached to the 12 lead Holter ECG. ECGs will be analysed after blinding of names and reason of call (code) to the investigators. The primary outcome will be ST-T segment changes greater than 0.1mV in two corresponding leads for more than 30 seconds per 100 calls.

As secondary outcomes, other ECG changes such as ST-T segment changes <0.1mV, T wave inversion or HRV will be analysed. Furthermore, surrogate parameter of stress will be measured using NASA-Task Load Index and cognitive appraisal and correlated to ST-T segment changes. Correlations between different phases of calls, different indications of calls and ECG changes will be assessed. Furthermore, correlation between alarm codes apriori defined as stressfull using a delphi process and ST-T segment changes as well es surrogate parameters of stress will be assessed.

Conditions

ST-T Segment Changes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Emergency physicians

Emergency physicians doing shifts at the Medical University of Vienna's emergency response car will recieve a thorough cardiac pretesting. During shifts they will be attached to a Holter-ECG to detect changes in ST-T Segment and other ECG changes. Furthermore surrogate parameters of stress will be measured

Holter ECG

Intervention Type: DEVICE

A Holter ECG will be recorderd during shifts

Interventions

Holter ECG

A Holter ECG will be recorderd during shifts

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy emergency physicians doing shifts at the Medical University of Vienna's emergency response car

Exclusion Criteria

• Known pregnancy
• Pre-existing cardiac diseases (valvular heart disease > I°, any form of cardiomyopathy, history of coronary artery disease, history of myocarditis, any channelopathy, known high degree (>1% of all beats within 24h) premature atrial or ventricular beats or atrial fibrillation or conduction disturbance.
• Any antiarrhythmic therapy
• Any implanted cardiac device
• Manifest Hyperthyroidism
• Termination of exercise testing due to the commonly used criteria26 or not reaching 85% of maximal predicted load.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Mathias Maleczek

Registrar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mathias Maleczek, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

Maleczek M, Schebesta K, Hamp T, Burger AL, Pezawas T, Krammel M, Roessler B. ST-T segment changes in prehospital emergency physicians in the field: a prospective observational trial. Scand J Trauma Resusc Emerg Med. 2022 Jul 15;30(1):47. doi: 10.1186/s13049-022-01033-1.

Reference Type: DERIVED

PMID: 35841049 (View on PubMed)

Other Identifiers

1646/2019

Identifier Type: -

Identifier Source: org_study_id