Clinical Validation of Dozee’s Contactless Vital Sign Measurements
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Mean Absolute Error (MAE) of Dozee NcBP across the range of each vitals
研究概览
简要总结
The most common parameters supervised by healthcare professionals to monitor patients’ health are heart rate (HR), respiration rate (RR), blood pressure (BP), oxygen saturation (SpO2), and temperature1
Conventional techniques for continuous monitoring of HR and RR rely on sophisticated equipment like multi-lead ECG sensors2 and nasal thermistors or nasal cannulas3. Continuous BP measurement typically involves intra-arterial BP monitoring (ABP), where a catheter is inserted into the artery for continuous BP monitoring4. However, ABP procedures are invasive and pose risks such as infection, bleeding, and thrombosis5. They are mainly restricted to Intensive Care Units (ICU) and are usually limited to critically ill patients, sometimes discontinued within a week due to discomfort and complications. For other hospitalized patients, periodic non-invasive cuff-based BP (NiBP) measurements are common, often done once a day. However, obtaining these readings can be difficult, disruptive (especially during sleep), and unreliable6,7. These traditional methods for HR, RR, and BP measurements are cumbersome and necessitate a high level of patient cooperation, as well as clinical expertise for accurate implementation.
Turtle Shell Technologies Pvt. Ltd. ’s (TST) Dozee system is a non-invasive continuous vitals monitoring system. The device employs piezoelectric sensors to capture micro-vibrations caused by cardiac contractions, upper respiratory tract activity, and body movements. It is based on the concept of ballistocardiography (BCG). The Dozee system is made up of non-contact sensor sheet(s) whose signals are used to calculate HR, RR, and non-contact blood pressure (NcBP). To measure temperature, SpO2, and NiBP, contact accessories such as pulse oximeter, temperature probe, and cuff BP respectively have been integrated.
This is a single-arm, unblinded, prospective, observational non-randomized study. The study will include 400 +ICU patients who provide consent. This study is considered an observational study as no Dozee data will be shared with clinical staff or the subject that may influence care. The study duration of enrolment for each patient will be 24hrs-72hrs.
- Dias D, Paulo Silva Cunha J. Wearable Health Devices-Vital Sign Monitoring, Systems and Technologies. Sensors (Basel). 2018 Jul 25;18(8):2414. doi: 10.3390/s18082414. PMID: 30044415; PMCID: PMC6111409.
- Sandau KE, et.al., American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Cardiovascular Disease in the Young. Update to Practice Standards for Electrocardiographic Monitoring in Hospital Settings: A Scientific Statement From the American Heart Association. Circulation. Nov 7;136(19):e273-e344.(2017)
- Subbe, Christian Peter & Kinsella, Sean. (2018). Continuous Monitoring of Respiratory Rate in Emergency Admissions: Evaluation of the RespiraSenseâ„¢ Sensor in Acute Care Compared to the Industry Standard and gold standard. Sensors. 18. 2700. 10.3390/s18082700.
- Gravenstein J, Paulus D. Invasive Blood Pressure Monitoring. Clinical Monitoring in Practice. Philadelphia: JB Lippincott; 1987.
- Nguyen Y, Bora V. Arterial Pressure Monitoring. [Updated 2021 May 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK556127/
- Palatini P, Asmar R. Cuff challenges in blood pressure measurement. J Clin Hypertens (Greenwich). 2018 Jul;20(7):1100-1103. doi: 10.1111/jch.13301. PMID: 30003699; PMCID: PMC8030978.
- de Greeff A, Lorde I, Wilton A, Seed P, Coleman A, Shennan A. Calibration accuracy of hospital-based non-invasive blood pressure measuring devices. J Hum Hypertens. Jan 2010;24(1):58-63.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Consenting adults 18 to 99 years ICU patients They or legal representative are able and willing to provide written informed consent or have a legally authorized representative willing to provide written informed consent For NcBP Patients already on radial ABP line or whose BP is measured using cuff BP For RR Patients on continuous capnography monitoring For HR patients on continuous ECG monitoring Patients who have been screened for HR RR and or NcBP can be included for the data collection of SpO2 temperature and NiBP data.
排除标准
- •Currently pregnant Exhibit injuries deformities or other abnormalities that in the opinion of the investigator, may prevent proper placement of accessories Level of agitation or non-compliance too high to enroll Needs the use of equipments whose operation can interfere with Dozee signal A significant medical condition in the judgment of the investigator which may compromise the study testing procedures.
结局指标
主要结局
Mean Absolute Error (MAE) of Dozee NcBP across the range of each vitals
时间窗: At baseline
in comparison to gold standard
时间窗: At baseline
次要结局
- MAE of Dozee RR in comparison to gold standard(MAE of Dozee HR in comparison to gold standard)
研究者
DrYogesh Kothari
Bhagwan Mahaveer Jain Hospital
