Clinical Performance Testing of ECG Machine named Dr Cardio of Kavitul Technologies Pvt Ltd in comparison with already approved ECG Machine being use at the Participating Hospital Site
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1) To compare performance of test ECG machine with reference ECG machine by comparing manually measured values of Heart Rate (HR), R wave amplitude and intervals like RR, PR, QRS, QTc, QT/QTc ratio
研究概览
简要总结
**SCREENING (Day (-28) to 1)**Following procedures will be carried out during screening on or withing 28 days before of enrolment in the study.
· Written informed consent will be taken from the subject. No study related procedure will be conducted prior to obtaining written informed consent.
· Assessment of subject eligibility as per Inclusion and Exclusion criteria.
STUDY PROCEDURES (DAY 1)
Following procedures will be carried out as a part of study.
· Evaluation as per inclusion/exclusion criteria (if subject has undergone evaluation as per inclusion/exclusion criteria on day 1 as a part of screening, then same evaluation again on day 1 as a part of study procedure will not be required)
· Demographics (Age, Gender, Ethnicity and Race only) data capture
· Capturing Medication and Medical history
· Randomization
· Electrocardiography with both the ECG machine one by one as per randomization sequence
· Monitoring and capturing of AE/SAE (if any)
· Clinical Performance Variable Evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Any healthy subject who voluntarily ready to undergo electrocardiography or any patients who voluntarily ready to undergo electrocardiography
- •Any volunteer who gives informed consent to participate in this study.
排除标准
- •Critically ill and clinically unstable patient who may not be comfortable to undergo electrocardiography
- •Patient having any psychological illness which may compromise the patient’s compliance / co-operation for electrocardiography.
结局指标
主要结局
1) To compare performance of test ECG machine with reference ECG machine by comparing manually measured values of Heart Rate (HR), R wave amplitude and intervals like RR, PR, QRS, QTc, QT/QTc ratio
时间窗: 2 minutes
2) To compare physician’s overall ease of reviewing the ECG waveforms captured using test ECG machine vs reference ECG machine
时间窗: 2 minutes
次要结局
- 1) To compare number of errors happening with test ECG machine vs reference ECG machine(2) To study user’s convenience with the test ECG machine and to compare it with reference ECG machine)
研究者
Dr Sanket Saraiya
Parul Sevashram Hospital