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ST-T Segment Changes in Emergency Physicians While on Duty

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ClinicalTrials.gov Identifier: NCT04003883
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mathias Maleczek, Medical University of Vienna

Tracking Information
First Submitted Date June 25, 2019
First Posted Date July 1, 2019
Last Update Posted Date November 19, 2019
Actual Study Start Date November 1, 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04003883 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 28, 2019)
  • ST-T segment change <0.1mV, <30sec. [ Time Frame: Day1-3 ]
  • T wave inversion > 30sec. [ Time Frame: 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
  • 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 ]
  • Association of different phases of a call to changes in HRV (SDNN, r-MSSD and pNN50) [ Time Frame: 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 ]
  • Association of the ten most stressful alarm codes to changes in HRV (SDNN, r-MSSD and pNN50) [ Time Frame: Day1-3 ]
  • Psychological stress during calls by means of NASA TLX [ Time Frame: Day1-3 ]
  • Frequency of calls being perceived as threat by using cognitive appraisal testing [ Time Frame: Day1-3 ]
  • Association of stressful and non-stressful calls to psychological stress measured using NASA TLX [ Time Frame: Day1-3 ]
  • Association of stressful and non-stressful calls to cognitive appraisal and calls that are perceived as threat. [ Time Frame: 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.
  • Association of NASA TLX to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec. [ Time Frame: Day1-3 ]
  • Association of cognitive appraisal to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec. [ Time Frame: Day1-3 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ST-T Segment Changes in Emergency Physicians While on Duty
Official Title ST-T Segment Changes in Emergency Physicians While on Duty
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples
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.
Condition ST-T Segment Changes
Intervention Device: Holter ECG
A Holter ECG will be recorderd during shifts
Study Groups/Cohorts 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
Intervention: Device: Holter ECG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 28, 2019)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 68 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mathias Maleczek, MD 06769174887 mathias.maleczek@meduniwien.ac.at
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT04003883
Other Study ID Numbers 1646/2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mathias Maleczek, Medical University of Vienna
Study Sponsor Medical University of Vienna
Collaborators Not Provided
Investigators
Principal Investigator: Mathias Maleczek, MD Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date November 2019