Clinical trial NCT04003883: ST-T Segment Changes in Emergency Physicians While on Duty
Official title: ST-T Segment Changes in Emergency Physicians While on Duty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-T Segment Changes
Keywords: ST segment
preclinical emergency medicine
stress
occupational health
emergency medicine
24h ECG
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Emergency physicians working at the Medical University of Vienna's emergency response cars will be invited to take part in this trial. Participants will be recruited by personalised phone contact, via email or direct approach and will not financially benefit for participation. The emergency physicians are anaesthesiologists and emergency medicine consultants and senior anaesthesia or emergency medical residents with prehospital emergency medicine credentials.

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.


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.

Primary outcomes:
measure: ST-T segment change
timeFrame: Day1-3
Secondary outcomes:
measure: ST-T segment change <0.1mV, <30sec.
timeFrame: Day1-3
measure: T wave inversion > 30sec.
timeFrame: Day1-3
measure: T wave inversion <= 30sec.
timeFrame: Day1-3
measure: Changes in HRV
timeFrame: Day1-3
measure: Association of different phases of a call to changes in ST-T segments > 0.1mV in two corresponding leads for > 30sec.
timeFrame: Day1-3
measure: Association of different phases of a call to changes in HRV (SDNN, r-MSSD and pNN50)
timeFrame: Day1-3
measure: Association of the ten most stressful alarm codes to changes in ST-T segments > 0.1mV in two corresponding leads for > 30sec.
timeFrame: Day1-3
measure: Association of the ten most stressful alarm codes to changes in HRV (SDNN, r-MSSD and pNN50)
timeFrame: Day1-3
measure: Psychological stress during calls by means of NASA TLX
timeFrame: Day1-3
measure: Frequency of calls being perceived as threat by using cognitive appraisal testing
timeFrame: Day1-3
measure: Association of stressful and non-stressful calls to psychological stress measured using NASA TLX
timeFrame: Day1-3
measure: Association of stressful and non-stressful calls to cognitive appraisal and calls that are perceived as threat.
timeFrame: Day1-3
measure: Correlation of events logged
timeFrame: Day1-3
measure: Association of NASA TLX to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec.
timeFrame: Day1-3
measure: Association of cognitive appraisal to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec.
timeFrame: Day1-3
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Mathias Maleczek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.