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

NCT07773636 | Not Yet Recruiting

• 1 other identifier: 49RC25_0490
• Study Type: interventional
• Target: 2,450
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ECG

Keywords

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

Outcome Measures

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.

  Baseline

Secondary Outcomes (3)

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

  Baseline

• 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 questionnaire

  through study completion, an average 2 years

Study Arms (2)

Nursing assitant

EXPERIMENTAL

Procedure: electrocardiogram by nursing assistant

Current practices

ACTIVE COMPARATOR

Procedure: electrocardiogram

Interventions

electrocardiogram by nursing assistant PROCEDURE

ECG are made by nursing assistant

Nursing assitant

electrocardiogram PROCEDURE

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

Current practices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucile Lucile.Bruere@chu-angers.fr

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucile BRUERE

CONTACT

241353637; Lucile.Bruere@chu-angers.fr

Lucile BRUERE

CONTACT

Lucile.Bruere@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): October 24, 2026
• Primary Completion (Estimated): October 23, 2028
• Study Completion (Estimated): October 23, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08