EMUs: Enhanced Monitoring Using Sensors After Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Wearable Wireless Sensor: Stage III is a shadow mode evaluation of the device with participants wearing sensors pre-, intra-, and post-operatively. Sensor and clinical data will be collected contemporaneously in the clinical environment. No sensor data is made available to clinical teams for decision making, with no change in patient care.

Study summary

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:

1. To perform usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment.
2. To determine baseline postoperative monitoring practice across our network and perform device usability testing in clinical environment.
3. 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.

Eligibility

Primary outcome measure(s)

• Cardiovascular data from wearable device — 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.
• Respiratory data from wearable device — 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 — 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.

Trial sites (17)

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