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An Evaluation Study of Nursing Assistants' Performance of Electrocardiograms in Emergency Departments as Part of a Delegation of Medical Procedures

An Evaluation Study of Nursing Assistants' Performance of Electrocardiograms in Emergency Departments as Part of a Delegation of Medical Procedures

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07773636
Acronym
ECGSU1
Enrollment
2450
Registered
2026-08-19
Start date
2026-10-24
Completion date
2028-10-23
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ECG

Keywords

nursing assistant, ECG interpretability criteria, act delegation, emergency department

Brief 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. 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.

Interventions

PROCEDUREelectrocardiogram by nursing assistant

ECG are made by nursing assistant

PROCEDUREelectrocardiogram

ECG are made by care workers in current practices (doctors, medical students, nurses)

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of compliance with ECG interpretability criteria when ECGs are performed by nursing assistants compared to healthcare professionals in routine practiceBaselineThe 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.

Secondary

MeasureTime frame
Measure of time for making ECG between admission, randomisation and making itBaseline
suitability ratio for ECG interpretability criteria between groups in the context of chest pain protocol (secondary)Baseline
team acceptability of the protocol implementation using a satisfaction questionnairethrough study completion, an average 2 years

Contacts

CONTACTLucile BRUERE
Lucile.Bruere@chu-angers.fr241353637
PRINCIPAL_INVESTIGATORLucile Lucile.Bruere@chu-angers.fr

University Hospital of Angers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026