EMUs: Enhanced Monitoring Using Sensors After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,332
- 试验地点
- 19
- 主要终点
- Respiratory data from wearable device
研究概览
简要总结
Patients can become critically unwell following surgical operations. Delay in recognition of this deterioration can result in patient harm and even death. Wearable wireless sensors that record patients vital signs such as heart rate could help improve recognition of patient deterioration. The goal of this observational study: Enhanced Monitoring Using Sensors After Surgery (EMUs) is to determine if data from wearable physiological monitors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff. The study participants and surgical inpatients undergoing open surgery. There are 3 objectives which each represent a stage of the study:
- To perform usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment.
- To determine baseline postoperative monitoring practice across our network and perform device usability testing in clinical environment.
- To perform a shadow-mode cohort study with collection of time-stamped sensor clinical event data to determine relationships between physiological waveforms and patient deterioration.
This registration focuses on the shadow-mode cohort study.
Participants will wear wireless sensors on their chest and fingers, pre-, intra-, and post-operatively for up to 10 days. The sensors will record their vital signs such as heart rate, and oxygen levels. This will then be analysed, and used to aid the design of early detection algorithms that may be able to predict clinical illness or complications in this patient group. This is an observational study gathering real time data only. No changes in patient care will result, and in Stages 2 and 3 no sensor data will be available to clinical teams. This study will be performed in departments of general surgery in Benin, Ghana, Guatemala, India, Mexico, Nigeria, Rwanda, and the United Kingdom.
详细描述
Patients who die after surgery frequently have treatable complications which are not identified in a timely manner. This is due to a failure to "recognize", "relay" or "react" to the deterioration of a patient in the postoperative period. This study aims to determine whether data from wearable physiological monitors can be used for the early detection of patient deterioration, while being acceptable to patients and healthcare staff. If found useful, future studies would be conducted to determine the performance and safety of such a device.
This study has three objectives which will be addressed in three stages.
STAGE 1. Usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment.
STAGE 2. Baseline postoperative monitoring practice assessment and device usability testing in clinical environment.
STAGE 3. Shadow-mode cohort study with collection of time-stamped sensor and clinical event data to determine relationships between physiological waveforms and patient deterioration.
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
- •Participant Inclusion Criteria:
- •Adults 18 years and older.
- •Undergoing an elective or emergency major surgery procedure with a planned skin incision of 5 cm or greater. Any indication for surgery can exist, including benign, malignant, and trauma.
- •Willing and able to provide written informed consent.
- •Participant
排除标准
- •Those under the age of
- •A documented or suspected allergy to adhesive dressings.
- •Obstetric patients
- •Unwilling or unable to provide written informed consent.
研究组 & 干预措施
Study Cohort
All surgical patients that fit the study eligibility criteria.
干预措施: Wearable Wireless Sensor (Device)
结局指标
主要结局
Respiratory data from wearable device
时间窗: 0-10 days from device application.
Data includes core vital sign measures to assess the patient's respiratory function (e.g. oxygen saturation as a percentage), advanced indices (e.g, Heart Rate (HR) /Respiratory Rate (RR) quotient) and raw waveform data.
Body temperature data from wearable device
时间窗: 0-10 days from device application.
Data includes core vital sign measures (e.g. temperature measurement in degrees centigrade), advanced indices, and raw waveform data.
Cardiovascular data from wearable device
时间窗: 0-10 days from device application.
Data includes core vital sign measures to assess the patient's cardiovascular function (e.g. heart rate in beats per minute), advanced indices (e.g., pulse arrival time, Heart Rate (HR) /Respiratory Rate (RR) quotient) and raw waveform data.
次要结局
- Incidence of clinical interventions during the study period(0-10 days from the day of device application.)
- Standard-of-care temperature vital sign observation data(0-10 days from day of device application.)
- Standard-of-care cardiovascular vital sign observation data(0-10 days from day of device application.)
- Standard-of-care neurological observation data(0-10 days from day of device application.)
- Incidence of clinical complications during the study period(0-10 days from the day of device application and then 30 day follow up will be performed.)
- Standard-of-care respiratory vital sign observation data(0-10 days from day of device application.)
- Incidence of clinical investigations during the study period(0-10 days from the day of device application.)
- Incidence and results of blood tests to assess patient physiological status during the study period(0-10 days from the day of device application.)