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临床试验/NCT05029011
NCT05029011已完成不适用

Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)

Helen S. Driver, PhD1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2022年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
Oximetry - overnight comparison between the VTS and gold-standard PSG

研究概览

简要总结

The BRAEBON VTS is a low-cost, portable device that is being developed to take continuous and real-time vital sign measurements of COVID-19 patients, both in the hospital and home setting. This study is being undertaken to test the BRAEBON VTS and validate against industry standards.

详细描述

In response to the COVID-19 pandemic, the BRAEBON Vital Signs Monitor (VTS) has been developed with funding from the National Research Council of Canada Industrial Research Assistance Program through the federal government's Innovative Solutions Canada (ISC) program. The VTS will measure peripheral capillary oxygen saturation (SpO2) and pulse via photoplethysmography (PPG), temperature, blood pressure (BP), heart and respiration rates, electrocardiogram (ECG), head position and movement over a continuous period. This monitor can be used remotely, and importantly will be low-cost so it can be accessed widely. Data from the VTS is transmitted wirelessly to a portable basestation which is a smartphone or tablet device via a customized application. This study will test the VTS both within the clinical environment and in the remote home environment to see how well it monitors patients effected by COVID-19 needing care, as well as satisfying an unmet need for remote monitoring across the healthcare system.

This study will compare the newly developed VTS with an industry gold standard of polysomnography (PSG) in the sleep laboratory, or in the home with the MediByte Jr (home sleep apnea test).

Approximately 150 patients will be recruited to the study across two different settings which includes a hospital setting and a remote setting, within the home environment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

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

  • Patients requiring a sleep evaluation using polysomnography
  • People referred to the sleep clinic
  • Persons over the age of 18

排除标准

  • Unable and/or unwilling to consent
  • No access to home WIFI (applicable to participants local to Kingston undertaking the study in the home setting)

结局指标

主要结局

Oximetry - overnight comparison between the VTS and gold-standard PSG

时间窗: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

Time spent with oxygen saturation \>=90%, time spent with oxygen saturation \<= 88%, number of desaturations of \>3%

Cardiac Rate (heart rate/pulse)

时间窗: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

beats per minute

Blood Pressure (BP)

时间窗: evening and morning, in a 24 hour period

mmHg

Body position (PSG and MediByte Jr) and head position (VTS)

时间窗: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

minutes spent supine, lateral and prone

Temperature (forehead)

时间窗: evening and morning, in a 24 hour period

degrees celcius

Identification of artifact

时间窗: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

e.g. movement

Respiratory rate

时间窗: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

breaths per minute

次要结局

  • Develop guidelines for the VTS(Within 6 months)

研究者

发起方
Helen S. Driver, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Helen S. Driver, PhD

Dr. Helen S. Driver, Assistant Professor, Division of Respirology and Sleep Medicine, Dept. Medicine, Queen's University

Queen's University

研究点 (1)

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