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NCT Number: NCT07773636

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrocardiogram by nursing assistant

Procedure

ECG are made by nursing assistant

Electrocardiogram

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Measure of time for making ECG between admission, randomisation and making it

    Time frame: Baseline

  2. suitability ratio for ECG interpretability criteria between groups in the context of chest pain protocol (secondary)

    Time frame: Baseline

  3. team acceptability of the protocol implementation using a satisfaction questionnaire

    Time frame: through study completion, an average 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Lucile BRUERE

CONTACT

[email protected]

241353637 ext. +33

Lucile BRUERE

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: ECGSU1

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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