Validity of Real Time Multi Vital Monitoring using Remote monitoring Technology: A pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- 1.Correlate the vitals including temperature, heart rate, respiratory rate, oxygen saturation, ECG derived from MVM solution and Standard methods in healthy volunteers.
研究概览
简要总结
Healthy volunteers:
After taking the screening consent, subject will be examined by complete physical, clinical examination and laboratory screening investigation (CBP, FBS, RFT, LFT, CUE, Viral markers for HIV, HBsAg, HCV, ECG, Chest X-ray). The participants will be screened for COVID-19 through RTPCR methods 24 hours prior to the start of study. Once the subject is found eligible, the study procedure will be explained in detail and written informed consent will be obtained. The subjects will be instructed to refrained from smoking and caffeine containing beverages at least 24 hours before the study measurements. If all the eligibility criteria are met the subjects will be asked to report to the study site 12 hours prior to the study and will be in-housed overnight.
On the study day the procedure will be started after overnight fasting for 10 hours. The on-boarding with MVM solution will be performed in the morning, in a quite room with controlled temperature and continued for 24 hours. Then participant will be asked to sit comfortably on a chair for 2 hrs. Then vitals using the standard methods will be recorded periodically at -1, 0, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours respectively. To the participant, standard breakfast will be served after 2 hours and lunch at 6 hours post on-boarding. Subject will be kept at the research site until 24 hours. If the vitals are normal the subject will be allowed to discharge 30 minutes after off-boarding.
Patients:
The patients with confirmed diagnosis of coronary artery disease and stable on medication will be screened by complete physical, clinical examination and laboratory investigation (CBP, FBS, RFT, LFT, CUE, Viral markers for HIV, HBsAg, HCV, ECG, Chest X-ray). The patients will be screened for COVID-19 through RTPCR methods 24 hours prior to the start of study. If found to be eligible the MVM solution and Standard measurements will be obtained in the similar way as in the healthy volunteers for 24 hours under direct and continues supervision of the physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Volunteers 1.Healthy, adult male aged 18-45 years, with BMI 18.5- 25kg/m2 2.Subjects of normal health as determined by medical history and physical examination.
- •3.Subjects with screening lab values within normal limits or considered insignificant by physician / investigator.
- •4.Should comply with all study procedures Patient: 1.Known CAD patient, stable on treatment.
- •2.Either gender and aged 18 to 65 years.
- •3.Should comply with all study procedures.
排除标准
- •Healthy volunteers 1.History of Contact dermatitis or hypersensitivity to patch material.
- •2.Regular smoker and has difficulty abstaining from smoking for 48 hours before study 3.Subjects with clinically significant physical disabilities Patients 1.History of Contact dermatitis or hypersensitivity to patch material.
- •2.Regular smoker and has difficulty abstaining from smoking for 48 hours before study 3.Subjects with clinically significant physical disabilities.
结局指标
主要结局
1.Correlate the vitals including temperature, heart rate, respiratory rate, oxygen saturation, ECG derived from MVM solution and Standard methods in healthy volunteers.
时间窗: 0, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours respectively.
次要结局
- Correlate the vitals including temperature, heart rate, respiratory rate, oxygen saturation, ECG derived from MVM solution and Standard methods in Coronary heart disease patients.(0, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours receptively.)