EMUs: Enhanced Monitoring Using Sensors After Surgery

NCT06565559 | Recruiting FDA Device

• 2 other identifiers: EMUs13344828
• Study Type: observational
• Target: 1,332
• Locations: 8 countries
• Sites: 17

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

Conditions

Surgery; Inpatients

Keywords

Surgery; Wearable Devices; Global Surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Standard-of-care cardiovascular vital sign observation data

  0-10 days from day of device application.

• Standard-of-care respiratory vital sign observation data

  0-10 days from day of device application.

• Standard-of-care temperature 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.

Study Arms (1)

Study Cohort

All surgical patients that fit the study eligibility criteria.

Device: Wearable Wireless Sensor

Interventions

Wearable Wireless Sensor DEVICE

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 Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Those under the age of 18.
• A documented or suspected allergy to adhesive dressings.
• Obstetric patients
• Unwilling or unable to provide written informed consent.

Sponsors & Collaborators

• University of Edinburgh: lead
• 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

Study Sites (17)

Hopital de Zone Atlantique Ouidah

Ouidah, Atlantique Department, Benin

RECRUITING

Centre Hospitalier Universitaire Departemental Borgou-Alibori

Parakou, Borgou Department, Benin

RECRUITING

Centre Hospitalier Universitaire Mere Enfant Lagune

Cotonou, Littoral Department, Benin

RECRUITING

Centre Hospitalier Universitaire et Departemental Oueme Plateau

Porto-Novo, Oeume, Benin

RECRUITING

Berekum Holy Family Hospital

Berekum, Berekum East, Ghana

RECRUITING

Techiman Holy Family Hospital

Techiman, Bono East, Ghana

RECRUITING

Tamale Teaching Hospital

Tamale, Ghana

RECRUITING

Hospital General San Juan de Dios

Guatemala City, Guatemala

RECRUITING

Lady Willingdon Hospital

Manali, Himachal Pradesh, India

RECRUITING

Padhar Hospital

Pādhar, Madhya Pradesh, India

RECRUITING

Christian Medical College and Hospital

Ludhiana, Punjab, India

RECRUITING

Hospital Español de Veracruz

Veracruz, Mexico

RECRUITING

Obafemi Awolowo University Teaching Hospital Complex

Ife, Nigeria

NOT YET RECRUITING

Lagos State University Teaching Hospital

Ikeja, Nigeria

NOT YET RECRUITING

Lagos University Teaching Hospital

Lagos, Nigeria

RECRUITING

University Teaching Hospital of Rwanda

Kigali, Rwanda

NOT YET RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (3)

• Burke JR, Downey C, Almoudaris AM. Failure to Rescue Deteriorating Patients: A Systematic Review of Root Causes and Improvement Strategies. J Patient Saf. 2022 Jan 1;18(1):e140-e155. doi: 10.1097/PTS.0000000000000720.

  PMID: 32453105 BACKGROUND

• Ghaferi AA, Birkmeyer JD, Dimick JB. Variation in hospital mortality associated with inpatient surgery. N Engl J Med. 2009 Oct 1;361(14):1368-75. doi: 10.1056/NEJMsa0903048.

  PMID: 19797283 BACKGROUND

• Jiwa A, Cameron MM, Ademuyiwa AO, Adisa A, Aguilera Arevalo ML, Bahrami Hessari M, Bhangu A, Brennan PM, Clark N, Cresswell K, Czerwinska I, D'Adderio L, Gunn E, Haque PD, Ikegwuonu T, Lawani I, Morton D, Nganwa A, Ntirenganya F, Pius R, Ramos de la Medina A, Samuel S, Shaw CA, Tabiri S, Townsend RC, Varghese C, Ghosh D, Harrison EM; NIHR Global Health Research Unit on Global Surgery. Continuous physiological monitoring for the detection of postoperative deterioration: a protocol for a multistage, multicentre, international, prospective cohort study. BMJ Open. 2025 Oct 6;15(10):e104463. doi: 10.1136/bmjopen-2025-104463.

  PMID: 41057181 DERIVED

Study Officials

• Ewen Harrison

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewen Harrison

CONTACT

+44 (0)131 651 7869; ewen.harrison@ed.ac.uk

Eilidh Gunn

CONTACT

+44 (0)131 651 7869; egunn3@ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: August 22, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

GH (3); IN (3); GU (1); NG (3); RW (1); ME (1); BE (4); GB (1)