EMUs: Enhanced Monitoring Using Sensors After Surgery
NCT Number: NCT06565559
Acronym: EMUs
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Surgery|Inpatients
Interventions: DEVICE: Wearable Wireless Sensor
Sponsor: University of Edinburgh
Collaborators: University of Birmingham|University for Development Studies, Tamale, Ghana|Hospital San Juan de Dios Guatemala|Christian Medical College and Hospital, Ludhiana, India|Hospital Español de Veracruz, Veracruz, Mexico|University of Rwanda|University of Lagos, Nigeria|School of health sciences, University of Abomey Calavi, Benin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1332
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-28
Completion Date: 2026-04
Locations: Tamale Teaching Hospital, Tamale, Ghana|Hospital General San Juan de Dios, Guatemala City, Guatemala|Christian Medical College and Hospital, Ludhiāna, India|Hospital Español de Veracruz, Veracruz, Mexico|Obafemi Awolowo University Teaching Hospital Complex, Ife, Nigeria|Lagos State University Teaching Hospital, Ikeja, Nigeria|Lagos University Teaching Hospital, Lagos, Nigeria|University Teaching Hospital of Rwanda, Kigali, Rwanda|Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, United Kingdom

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.

Primary Outcome Measures: Cardiovascular data from wearable device, 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., 0-10 days from device application.|Respiratory data from wearable device, 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., 0-10 days from device application.|Body temperature data from wearable device, Data includes core vital sign measures (e.g. temperature measurement in degrees centigrade), advanced indices, and raw waveform data., 0-10 days from device application.
Secondary Outcome Measures: Standard-of-care cardiovascular vital sign observation data, Standard-of-care vital sign observation data to assess cardiovascular function e.g. heart rate in beats per minute, blood pressure in mmHg at a frequency normally collected. These will be assessed as part of the National Early Warning Score 2 system (NEWS2) which a validated early warning score for detecting patient deterioration or equivalent in participating centers., 0-10 days from day of device application.|Standard-of-care respiratory vital sign observation data, Standard-of-care vital sign observation data to assess respiratory function e.g. respiratory rate in breaths per minute, oxygen saturations in percentage, at a frequency normally collected. These will be assessed as part of the National Early Warning Score 2 system (NEWS2) which a validated early warning score for detecting patient deterioration, or equivalent in participating centers., 0-10 days from day of device application.|Standard-of-care temperature vital sign observation data, Standard-of-care vital sign observation data to assess temperature e.g. in degrees centigrade or Fahrenheit, at a frequency normally collected. These will be assessed as part of the National Early Warning Score 2 system (NEWS2) which a validated early warning score for detecting patient deterioration or equivalent in participating centers., 0-10 days from day of device application.|Standard-of-care neurological observation data, Standard-of-care vital sign observation data to assess neurological function e.g. Alert Verbal Pain Unresponsive (AVPU) at a frequency normally collected. These will be assessed as part of the National Early Warning Score 2 system (NEWS2) which a validated early warning score for detecting patient deterioration or equivalent in participating centres., 0-10 days from day of device application.|Incidence of clinical complications during the study period, Incidence of clinical diagnosis data such as bleeding, major adverse cardiac event, sepsis will be derived from patient records and recorded and any uncertainty reviewed post hoc by an expert adjudication panel. Clinical complication data will also be gathered at 30 days., 0-10 days from the day of device application and then 30 day follow up will be performed.|Incidence of clinical investigations during the study period, The incidence of clinical investigations and descriptive details about the investigations will be derived from the patient records such as chest xray, CT abdomen, and wound swab., 0-10 days from the day of device application.|Incidence of clinical interventions during the study period, The incidence of clinical interventions performed and descriptive details, during the period of the device being worn will be recorded, e.g. commencement of antibiotics, unplanned admission to critical care, unplanned reoperation., 0-10 days from the day of device application.|Incidence and results of blood tests to assess patient physiological status during the study period, The incidence of blood tests will be recorded and the associated results from during the 10 day study period. Bloods tests recorded will include full blood count, urea and electrolytes, inflammatory markers, liver function tests and coagulation profile as well as blood gas results. They will be recorded using whichever the standard units are at participating centres., 0-10 days from the day of device application.