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

ConditionECG
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • electrocardiogram by nursing assistant

    Procedure/Surgery

    ECG are made by nursing assistant

  • electrocardiogram

    Procedure/Surgery

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

Treatment groups

2,450 Participants
are divided into 2 treatment groups
Group A: Nursing assitantExperimental treatment 1 intervention
Group B: Current practicesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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