Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Systolic blood pressure difference from reference measurement (mmHg)
研究概览
简要总结
The impact of the coronavirus disease (COVID)-19 pandemic on global healthcare systems has prompted a search for novel tools to stem the tide. New digital health tools can provide possible health solutions in this time of unprecedented medical crisis to mitigate the impact of this pandemic. This proof of concept study will determine the feasibility and effectiveness of implementing a mobile application for contactless screening and vital signs measurement (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR), oxyhemoglobin saturation (SpO2), temperature from surgical patients peri-operatively. Contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments.
详细描述
This study aims to determine whether a mobile app can accurately and reliably measure vital signs without any person to person contact, and the feasibility of implementing it in a peri-operative setting (e.g., during COVID-19). The validity and feasibility of the Anura™ Research app will be assessed during inpatient visits in preparation for and after surgery, and it will be compared with standard medical monitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective surgery under general and/or regional anesthesia
- •18+ years of age
排除标准
- •Refusal to consent for the study
- •Non-English speaking
结局指标
主要结局
Systolic blood pressure difference from reference measurement (mmHg)
时间窗: Perioperative
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Diastolic blood pressure difference from reference measurement (mmHg)
时间窗: Perioperative
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Blood oxygenation (SpO2) difference from reference measurement (% oxyhemoglobin saturation)
时间窗: Perioperative
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (% oxyhemoglobin saturation)
Pulse rate difference from reference measurement (beats per minute)
时间窗: Perioperative
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute)
Teperature difference from reference measurement (degrees Celsius)
时间窗: Perioperative
Assessed against standard clinical grade instrument: Forehead digital thermometer (degrees Celsius)
Respiratory rate difference from reference measurement (breaths per minute)
时间窗: Perioperative
Assessed against standard clinical grade instrument: Visual count of chest rise and fall (breaths per minute)
Obstacles to using the mobile application
时间窗: Perioperative
Characterization of obstacles to the implementation of the mobile app for perioperative vital sign measurements.
次要结局
- Detection rate of clinically meaningful changes of vital signs(Perioperative)
- Ease of use survey(Perioperative)
- Satisfaction survey(Perioperative)
- Study participation(Perioperative)
- Compliance with measurement protocol(Perioperative)