ECGECGSU1NCT07773636
An Evaluation Study of Nursing Assistants' Performance of Electrocardiograms in Emergency Departments as Part of a Delegation of Medical Procedures
A study testing electrocardiogram by nursing assistant and electrocardiogram in people with ECG, run by University Hospital, Angers.
Trial summary
ECG is a simple diagnosis tool which provide a lot of diagnosis and therapeutic decisions. The last few years, the admission number in french emergency department increases in parallel with the ECG acquisition request. ECG acquisition is often made by a nurse, medical skill legally delegate to nurse since 2002. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ECG
- What is being tested?
- electrocardiogram by nursing assistant and electrocardiogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,450 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2026to 23 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all major and conscient patient admit in the emergency departement of CHU of Angers
- indication of ECG aquisition in the emergency room reception under prescription medical and/or in context of pre-established protocols
- patient who has been affiliated or beneficiary from social security system
- patient deliberate consent
Who cannot join
- people under L1121-5 to L1121_8 of french law public heath articles, namely pregnant women, laboring women, nursing women, people deprived of freedom from legal decision, minor, people under legal protection (guardianship)
- people involved in another interventional study changing standard of care or could influence study evaluation criterias
- pacemaker carrier
- unable to free consent
- medical emergency needing immediate ECG acquisition
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lucile BRUERE contact
About this study
ECG is a simple diagnosis tool which provide a lot of diagnosis and therapeutic decisions. The last few years, the admission number in french emergency department increases in parallel with the ECG acquisition request. ECG acquisition is often made by a nurse, medical skill legally delegate to nurse since 2002. Outside hospital, since 2022, a ministerial decree has extended ECG acquisition to first-aider. The medical delegation of ECG acquisition to nursing assistant could be a way to give back nursing time and would allow to make ECG faster. ECGSU 1 study investigates if the ECG acquisition by a nursing assistant in emergency room reception, for patients admit in emergency department, is qualitatively performant in compare to qualified workers.
Materials and Method ECGSU 1 study is a non-inferiority, transversal, monocentric, prospective and open trial. The study compares the suitability ratio for ECG's interpretability criteria of ECG made by nursing assistant and made by care workers in current practices (doctors, medical students, nurses). The ECG's interpretability criteria are defined by actual recommendations. The suitability ratio for ECG's interpretability criteria will be considered as reliable if all the interpretability criteria are fulfilled for ECG examination. This examination will be conducted by a blind adjudication committee. 2450 patients will be recruited in 24 months in the emergency department of the CHU of Angers.
- Conditions
- ECG
- Being tested
- electrocardiogram by nursing assistant, electrocardiogram
- Keywords
- nursing assistant, ECG interpretability criteria, act delegation, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiogram by nursing assistantProcedure or surgery
ECG are made by nursing assistant
electrocardiogramProcedure or surgery
ECG are made by care workers in current practices (doctors, medical students, nurses)
| Study group | Role | What they receive |
|---|---|---|
| Nursing assitant | Experimental | Not described Receives: Procedure: electrocardiogram by nursing assistant |
| Current practices | Active comparator | Not described Receives: Procedure: electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of compliance with ECG interpretability criteria when ECGs are performed by nursing assistants compared to healthcare professionals in routine practice
The suitability ratio for ECG interpretability criteria will be considered as reliable if all the interpretability criteria are fulfilled for ECG examination. This examination will be conducted by a blind adjudication committee.
Measured: Baseline
Secondary outcomes (3)
Measure of time for making ECG between admission, randomisation and making it
Measured: Baseline
suitability ratio for ECG interpretability criteria between groups in the context of chest pain protocol (secondary)
Measured: Baseline
team acceptability of the protocol implementation using a satisfaction questionnaire
Measured: through study completion, an average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start24 Oct 2026 (estimated)
- Primary completion23 Oct 2028 (estimated)
- Study completion23 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECGStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lucile Lucile.Bruere@chu-angers.fr, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773636
- Sponsor's protocol ID
- 49RC25_0490
- Acronym
- ECGSU1
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation Study of Nursing Assistants' Performance of Electrocardiograms in Emergency Departments as Part of a Delegation of Medical Procedures
- ClinicalTrials.gov ID
- NCT07773636
- Acronym / sponsor ID
- ECGSU1 / 49RC25_0490
- Conditions
- ECG
- Keywords
- nursing assistant, ECG interpretability criteria, act delegation, emergency department
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,450 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 24 Oct 2026 (estimated)
- Primary completion
- 23 Oct 2028 (estimated)
- Study completion
- 23 Oct 2028 (estimated)
- First posted
- 19 Aug 2026 (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.
ECG is a simple diagnosis tool which provide a lot of diagnosis and therapeutic decisions. The last few years, the admission number in french emergency department increases in parallel with the ECG acquisition request. ECG acquisition is often made by a nurse, medical skill legally delegate to nurse since 2002. Outside hospital, since 2022, a ministerial decree has extended ECG acquisition to first-aider. The medical delegation of ECG acquisition to nursing assistant could be a way to give back nursing time and would allow to make ECG faster. ECGSU 1 study investigates if the ECG acquisition by a nursing assistant in emergency room reception, for patients admit in emergency department, is qualitatively performant in compare to qualified workers.
Materials and Method ECGSU 1 study is a non-inferiority, transversal, monocentric, prospective and open trial. The study compares the suitability ratio for ECG's interpretability criteria of ECG made by nursing assistant and made by care workers in current practices (doctors, medical students, nurses). The ECG's interpretability criteria are defined by actual recommendations. The suitability ratio for ECG's interpretability criteria will be considered as reliable if all the interpretability criteria are fulfilled for ECG examination. This examination will be conducted by a blind adjudication committee. 2450 patients will be recruited in 24 months in the emergency department of the CHU of Angers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing assitant | Experimental | Procedure: electrocardiogram by nursing assistant |
| Current practices | Active comparator | Procedure: electrocardiogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- all major and conscient patient admit in the emergency departement of CHU of Angers
- indication of ECG aquisition in the emergency room reception under prescription medical and/or in context of pre-established protocols
- patient who has been affiliated or beneficiary from social security system
- patient deliberate consent
Key exclusion criteria (5 listed)
- people under L1121-5 to L1121_8 of french law public heath articles, namely pregnant women, laboring women, nursing women, people deprived of freedom from legal decision, minor, people under legal protection (guardianship)
- people involved in another interventional study changing standard of care or could influence study evaluation criterias
- pacemaker carrier
- unable to free consent
- medical emergency needing immediate ECG acquisition
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 |
|---|---|---|
| electrocardiogram by nursing assistantECG are made by nursing assistant | Procedure or surgery | Nursing assitant |
| electrocardiogramECG are made by care workers in current practices (doctors, medical students, nurses) | Procedure or surgery | Current practices |
Primary outcome
Rate of compliance with ECG interpretability criteria when ECGs are performed by nursing assistants compared to healthcare professionals in routine practice
Time frame: Baseline
The suitability ratio for ECG interpretability criteria will be considered as reliable if all the interpretability criteria are fulfilled for ECG examination. This examination will be conducted by a blind adjudication committee.
3 secondary outcomes
Measure of time for making ECG between admission, randomisation and making it
Time frame: Baseline
suitability ratio for ECG interpretability criteria between groups in the context of chest pain protocol (secondary)
Time frame: Baseline
team acceptability of the protocol implementation using a satisfaction questionnaire
Time frame: through study completion, an average 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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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.
Lucile BRUERE contact
Lucile Lucile.Bruere@chu-angers.fr principal investigator
University Hospital of Angers
Questions about this trial
What is this clinical trial studying?
A study testing electrocardiogram by nursing assistant and electrocardiogram in people with ECG, run by University Hospital, Angers.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucile BRUERE (241353637 ext. +33, Lucile.Bruere@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of compliance with ECG interpretability criteria when ECGs are performed by nursing assistants compared to healthcare professionals in routine practice (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.