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临床试验/NCT07773636
NCT07773636尚未招募不适用

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

University Hospital, Angers0 个研究点目标入组 2,450 人开始时间: 2026年10月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,450
主要终点
Rate of compliance with ECG interpretability criteria when ECGs are performed by nursing assistants compared to healthcare professionals in routine practice

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Nursing assitant

Experimental

干预措施: electrocardiogram by nursing assistant (Procedure)

Current practices

Active Comparator

干预措施: electrocardiogram (Procedure)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

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