EMUs: Enhanced Monitoring Using Sensors After Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Edinburgh
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Those under the age of 18.
A documented or suspected allergy to adhesive dressings.
Obstetric patients
Unwilling or unable to provide written informed consent.
Trial population
The study population are all patients undergoing a surgical procedure at the NIHR Global Health Research Unit on Global Surgery hubs/spoke hospitals in India, Nigeria, Ghana, Guatemala, Mexico, Rwanda, Benin and the United Kingdom that fit the eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Wearable Wireless Sensor
DeviceStage 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.
Treatment groups
1,332 Participants
are divided into 1 treatment groupGroup A: Study Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
0-10 days from device application.2
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.
Time frame
0-10 days from device application.3
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.
Time frame
0-10 days from device application.Secondary outcomes
1
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.
Time frame
0-10 days from day of device application.2
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.
Time frame
0-10 days from day of device application.3
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.
Time frame
0-10 days from day of device application.4
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.
Time frame
0-10 days from day of device application.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Edinburgh
Lead sponsor
University of Birmingham
Collaborator
University for Development Studies, Tamale, Ghana
Collaborator
Hospital San Juan de Dios Guatemala
Collaborator
Christian Medical College and Hospital, Ludhiana, India
Collaborator
Hospital Español de Veracruz, Veracruz, Mexico
Collaborator
University of Rwanda
Collaborator
University of Lagos, Nigeria
Collaborator
School of health sciences, University of Abomey Calavi, Benin
Collaborator
Source ClinicalTrials.gov