跳至主要内容
临床试验/NCT04227418
NCT04227418Unknown不适用

An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry

The Leeds Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2020年1月24日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,500
试验地点
1
主要终点
ECG monitoring

研究概览

简要总结

Acetylcholinesterase inhibitors and antipsychotics are drugs commonly prescribed in psychiatry, the former for dementia and the latter for acute and chronic psychotic illness. Both can cause cardiac arrhythmia therefore 12 lead ECG's are recommended before prescribing. The test is often difficult to obtain however, leading to either patients being inconvenienced or drugs prescribed without the test. There are two parts of this study, but both examine the utility of single lead ecg monitoring, one in the memory clinic and the other in inpatient psychiatry wards. The aim to to evaluate the safety and efficacy of the handheld ecg versus the 12 lead and 6 lead ecg, and whether the handheld ecg can be used to screen for ecg abnormalities that would generally lead to a caution or contra-indication for acetylcholinesterase inhibitors and anti-psychotic medication.

Patients will either be recruited from the outpatient memory clinic or in patient psychiatry wards. Following informed consent baseline demographic data will be collected, and patients will undergo a 12 lead and 6 lead ECG as well as a rhythm strip using the handheld device. Data from this point will be annonymised for future analysis. The psychiatrists ECG report will also be recorded, and a subset of patients will undergo an echocardiogram (to see what proportion of patients with psychiatric disorders have structural heart disease.)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Any patient attending the memory clinic Any patient admitted to the acute psychiatric ward requiring antipsychotic medication

排除标准

  • Patients who lack capacity and do not have a personal consultee to provide assent

结局指标

主要结局

ECG monitoring

时间窗: 45 minutes

12 lead, 6 lead and handheld ECG device monitoring will be undertaken.

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验