跳至主要内容
临床试验/CTRI/2021/12/038849
CTRI/2021/12/038849进行中(未招募)不适用

Contactless Monitoring Of Body Vitals Using Ballistocardiogram

Turtle Shell Technologies Private Limited1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
1. Root mean square deviation (RMSD) of the Dozee’s HR and Gold Standard Devices

研究概览

简要总结

Heart Rate (HR), Respiration Rate (RR), and Oxygen Saturation (SpO2) are the most common vital signs used by medical professionals to monitor health of the patients. While a pulse oximeter is mostly used only to capture oxygen saturation, it can also be used to measure heart  rate, though ECG remains the gold standard for heart rate measurement. Respiration, on the other hand, is traditionally measured manually by the nursing staff but can also be measured using a nasal thermistor or capnography. Monitoring of these vitals with less cumbersome techniques would be ideal in long term monitoring of patients and healthy people to detect any sudden abnormalities and long-term health deterioration. During COVID-19 pandemic, remote monitoring devices have come up as champions to assist the healthcare workers in patient monitoring. Several advancements have been made in achieving continuous long-term monitoring of vitals using wrist watches, PPG sensors, etc. [1, 2]. But very few of these have been implemented with acceptable accuracy. The Dozee device developed by Turtle Shell Technologies Pvt. Ltd., is a non-contact continuous vital parameters monitoring system. It is designed for continuous and contactless measurement of HR HR, RR, and SpO2 (when connected with an accessory). The device uses the concept of ballistocardiography and deploys piezoelectric sensors to capture the micro-vibrations originating from cardiac contractions, upper respiratory tract activity and body movements. This data is then analyzed by a proprietary algorithm and the values of the vital parameters – HR and RR are generated. The sensor sheet is placed below the mattress and captures data while the user is resting or sleeping and does not require a sensor to be fixed to the body making it ideal when compared to current methods. Monitoring people’s vital signs outside an ICU often relies on nursing staff conducting checks at set intervals. The device can reduce the workload for nursing staff in non-ICU wards. This device is intended to be used to monitor individuals/patients greater than eighteen years of age (40 kg ≤ weight ≤ 120 kg) and can measure their vital signs during sleep and resting state. The data can be viewed on the dashboard, exported, and even be directly transferred to the in-house hospital management software. This protocol aims at verifying the effectiveness of the investigational device in a general-care clinical environment.

References

  1. Etiwy M, Akhrass Z, Gillinov L, et al. Accuracy of wearable heart rate monitors in cardiac rehabilitation [published correction appears in Cardiovasc Diagn Ther. 2020 Jun;10(3):644-645]. Cardiovasc Diagn Ther.2019;9(3):262-271. doi:10.21037/cdt.2019.04.08

  2. Charlton PH, Bonnici T, Tarassenko L, Clifton DA, Beale R, Watkinson PJ. An assessment of algorithms to estimate respiratory rate from the electrocardiogram and photoplethysmogram. Physiol Meas. 2016;37(4):610-626. doi:10.1088/0967-3334/37/4/610

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Adults (Above 18 years of age)
  • Provide written informed consent
  • Weight (Above 40 kgs)
  • Are located in a non-ICU hospital setting
  • Agree and able to not eat during the testing period
  • Agree and able to to keep still.

排除标准

  • Are connected to a device which may interfere with the device monitoring in this study, eg.
  • A likely need to receive or undergo a procedure/care during the testing period
  • Have a pacemaker or defibrillator
  • Cannot accept a nasal cannula, or have a monitor lead placed on the chest
  • A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.

结局指标

主要结局

1. Root mean square deviation (RMSD) of the Dozee’s HR and Gold Standard Devices

时间窗: At Baseline

HR

时间窗: At Baseline

â—‹ Simultaneously record HR in both devices and calculate and compare the

时间窗: At Baseline

RMSD per patient and the Bland-Altman Plot

时间窗: At Baseline

RR

时间窗: At Baseline

2. Root mean square deviation (RMSD) of the Dozee’s RR and Gold Standard Devices

时间窗: At Baseline

â—‹ Simultaneously record RR in both devices and calculate and compare the

时间窗: At Baseline

3. Root mean square deviation (RMSD) of the Dozee’s SpO2 and Gold Standard Devices

时间窗: At Baseline

SpO2

时间窗: At Baseline

â—‹ Simultaneously record SpO2 in both devices and calculate and compare the

时间窗: At Baseline

次要结局

未报告次要终点

研究者

申办方类型
Other [Medical Device]

研究点 (1)

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