An Evaluation Study of Nursing Assistants' Performance of Electrocardiograms in Emergency Departments as Part of a Delegation of Medical Procedures
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
- 否
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
干预措施: electrocardiogram by nursing assistant (Procedure)
Current practices
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)
