ST-T Segment Changes in Emergency Physicians While on Duty

February 13, 2022 updated by: Mathias Maleczek, Medical University of Vienna

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
A Holter ECG will be recorderd during shifts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ST-T segment change
Time Frame: Day1-3
ST-T segment changes of at least 0.1mV in two corresponding leads occurring for more than 30 seconds per 100 prehospital emergency response calls
Day1-3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ST-T segment change <0.1mV, <30sec.
Time Frame: Day1-3
Day1-3
T wave inversion > 30sec.
Time Frame: Day1-3
Day1-3
T wave inversion <= 30sec.
Time Frame: Day1-3
Day1-3
Changes in HRV
Time Frame: Day1-3
Changes in HRV (SDNN, r-MSSD and pNN50) during calls compared to a baseline of 10min rest recorded at the beginning of shift as an emergency physician
Day1-3
Association of different phases of a call to changes in ST-T segments > 0.1mV in two corresponding leads for > 30sec.
Time Frame: Day1-3
Day1-3
Association of different phases of a call to changes in HRV (SDNN, r-MSSD and pNN50)
Time Frame: Day1-3
Day1-3
Association of the ten most stressful alarm codes to changes in ST-T segments > 0.1mV in two corresponding leads for > 30sec.
Time Frame: Day1-3
Day1-3
Association of the ten most stressful alarm codes to changes in HRV (SDNN, r-MSSD and pNN50)
Time Frame: Day1-3
Day1-3
Psychological stress during calls by means of NASA TLX
Time Frame: Day1-3
Day1-3
Frequency of calls being perceived as threat by using cognitive appraisal testing
Time Frame: Day1-3
Day1-3
Association of stressful and non-stressful calls to psychological stress measured using NASA TLX
Time Frame: Day1-3
Day1-3
Association of stressful and non-stressful calls to cognitive appraisal and calls that are perceived as threat.
Time Frame: Day1-3
Day1-3
Correlation of events logged
Time Frame: Day1-3
Correlation of events logged by the emergency physician (treating a child, managing polytrauma, being woken up by the alarm, experiencing chest pain, performing an intubation or giving i.v. medication) to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec.
Day1-3
Association of NASA TLX to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec.
Time Frame: Day1-3
Day1-3
Association of cognitive appraisal to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec.
Time Frame: Day1-3
Day1-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mathias Maleczek, MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

November 30, 2021

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (ACTUAL)

July 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 13, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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