Enhanced monitoring with wearable sensors after surgery
EMUs: Enhanced Monitoring Using Sensors After Surgery
This project will test whether wearable wireless sensors can spot early signs of deterioration in adults recovering from major surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1332 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 17 sites (Ouidah, Atlantique Department and 16 other locations) |
| Trial ID | NCT06565559 on ClinicalTrials.gov |
What this trial studies
This observational, multi-stage project uses wearable wireless sensors to collect continuous physiological data from adults after major open surgery in diverse hospital settings. Stage 1 tests device usability with clinicians and staff in non-clinical settings, Stage 2 documents baseline postoperative monitoring practices and performs device usability testing in wards, and Stage 3 runs a shadow-mode cohort where time-stamped sensor data are linked to clinical events. The protocol is device-agnostic and will be carried out in general surgery departments across Benin, Ghana, Guatemala, India, Mexico, Nigeria, Rwanda, and the United Kingdom. Collected waveform and vital-sign data will be analyzed to see if characteristic patterns occur before clinical deterioration.
Who should consider this trial
Good fit: Adults (18+) undergoing elective or emergency major open surgery with a planned skin incision of 5 cm or greater who can give written informed consent.
Not a fit: Children, obstetric patients, people with a known or suspected allergy to adhesive dressings, and patients unable or unwilling to provide written consent are excluded and may not benefit.
Why it matters
Potential benefit: If successful, earlier detection using wearable data could reduce postoperative complications, unplanned ICU admissions, and deaths.
How similar studies have performed: Smaller pilot studies and proof-of-concept projects have shown promise for wearable monitors in detecting deterioration, but large multi-country validation is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Participant Inclusion Criteria: * 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. Participant Exclusion Criteria: * Those under the age of 18. * A documented or suspected allergy to adhesive dressings. * Obstetric patients * Unwilling or unable to provide written informed consent.
Where this trial is running
Ouidah, Atlantique Department and 16 other locations
- 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, United Kingdom (Active_not_recruiting)
Study contacts
- Principal investigator: Ewen Harrison — University of Edinburgh
- Study coordinator: Ewen Harrison
- Email: ewen.harrison@ed.ac.uk
- Phone: +44 (0)131 651 7869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.