EMUs: Enhanced Monitoring Using Sensors After Surgery

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.

Conditions

• Surgery
• Inpatients

Interventions

DEVICE

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.

Sponsors & Collaborators

• University of Birmingham

  collaborator OTHER

• University for Development Studies, Tamale, Ghana

  collaborator OTHER

• Hospital San Juan de Dios Guatemala

  collaborator OTHER_GOV

• Christian Medical College and Hospital, Ludhiana, India

  collaborator OTHER

• Hospital Español de Veracruz, Veracruz, Mexico

  collaborator UNKNOWN

• University of Rwanda

  collaborator OTHER

• University of Lagos, Nigeria

  collaborator OTHER

• School of health sciences, University of Abomey Calavi, Benin

  collaborator UNKNOWN

• University of Edinburgh

  lead OTHER

Principal Investigators

• Ewen Harrison · University of Edinburgh

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-28

Primary Completion

2027-07-31

Completion

2027-07-31

FDA Device

Yes

Countries

• Benin
• Ghana
• Guatemala
• India
• Mexico
• Nigeria
• Rwanda
• United Kingdom

Study Locations