ST-T Segment ChangesNCT04003883
ST-T Segment Changes in Emergency Physicians While on Duty
An observational study of ST-T Segment Changes, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- ST-T Segment Changes
- What is being tested?
- Holter ECG
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2019to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy emergency physicians doing shifts at the Medical University of Vienna's emergency response car
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Holter ECG
- Keywords
- ST segment, preclinical emergency medicine, stress, occupational health, emergency medicine, 24h ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter ECGDevice
A Holter ECG will be recorderd during shifts
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Holter ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
ST-T segment change
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
Measured: Day1-3
Secondary outcomes (15)
ST-T segment change <0.1mV, <30sec.
Measured: Day1-3
T wave inversion > 30sec.
Measured: Day1-3
T wave inversion <= 30sec.
Measured: Day1-3
Changes in HRV
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
Measured: Day1-3
Association of different phases of a call to changes in ST-T segments > 0.1mV in two corresponding leads for > 30sec.
Measured: Day1-3
Association of different phases of a call to changes in HRV (SDNN, r-MSSD and pNN50)
Measured: Day1-3
Association of the ten most stressful alarm codes to changes in ST-T segments > 0.1mV in two corresponding leads for > 30sec.
Measured: Day1-3
Association of the ten most stressful alarm codes to changes in HRV (SDNN, r-MSSD and pNN50)
Measured: Day1-3
Psychological stress during calls by means of NASA TLX
Measured: Day1-3
Frequency of calls being perceived as threat by using cognitive appraisal testing
Measured: Day1-3
Association of stressful and non-stressful calls to psychological stress measured using NASA TLX
Measured: Day1-3
Association of stressful and non-stressful calls to cognitive appraisal and calls that are perceived as threat.
Measured: Day1-3
Correlation of events logged
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.
Measured: Day1-3
Association of NASA TLX to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec.
Measured: Day1-3
Association of cognitive appraisal to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec.
Measured: Day1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Nov 2019
- Primary completion1 May 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-T Segment ChangesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Maleczek, Medical University of Vienna
- Investigators
- Mathias Maleczek, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003883
- Sponsor's protocol ID
- 1646/2019
- Status last verified
- Feb 2022
- First submitted
- 25 Jun 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35841049
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ST-T Segment Changes in Emergency Physicians While on Duty
- ClinicalTrials.gov ID
- NCT04003883
- Acronym / sponsor ID
- 1646/2019
- Conditions
- ST-T Segment Changes
- Keywords
- ST segment, preclinical emergency medicine, stress, occupational health, emergency medicine, 24h ECG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency physicians | – | Device: Holter ECGEmergency 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 |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Healthy emergency physicians doing shifts at the Medical University of Vienna's emergency response car
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holter ECGA Holter ECG will be recorderd during shifts | Device | Emergency physicians |
Primary outcome
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
15 secondary outcomes
ST-T segment change <0.1mV, <30sec.
Time frame: Day1-3
T wave inversion > 30sec.
Time frame: Day1-3
T wave inversion <= 30sec.
Time frame: Day1-3
Changes in HRV
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Derived from this study: PubMed 35841049Maleczek 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Maleczek, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST-T Segment Changes, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ST-T segment change (time frame: Day1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.