EMUs: Enhanced Monitoring Using Sensors After Surgery
Recruiting now
Conditions studied: Surgery, Inpatients
In brief
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.
Key facts
- Study ID
- NCT06565559
- Run by
- University of Edinburgh
- People needed
- 1332
- Starts
- 2024-02-28
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Hopital de Zone Atlantique Ouidah — Ouidah, Atlantique Department, Benin (enrolling)
- Centre Hospitalier Universitaire Departemental Borgou-Alibori — Parakou, Borgou Department, Benin (enrolling)
- Centre Hospitalier Universitaire Mere Enfant Lagune — Cotonou, Littoral Department, Benin (enrolling)
- Centre Hospitalier Universitaire et Departemental Oueme Plateau — Porto-Novo, Oeume, Benin (enrolling)
- Berekum Holy Family Hospital — Berekum, Berekum East, Ghana (enrolling)
- Techiman Holy Family Hospital — Techiman, Bono East, Ghana (enrolling)
- Tamale Teaching Hospital — Tamale, Ghana (enrolling)
- Hospital General San Juan de Dios — Guatemala City, Guatemala (enrolling)
- Lady Willingdon Hospital — Manali, Himachal Pradesh, India (enrolling)
- Padhar Hospital — Pādhar, Madhya Pradesh, India (enrolling)
- Christian Medical College and Hospital — Ludhiana, Punjab, India (enrolling)
- Hospital Español de Veracruz — Veracruz, Mexico (enrolling)
- Lagos University Teaching Hospital — Lagos, Nigeria (enrolling)
- Lagos State University Teaching Hospital — Ikeja, Nigeria
- Royal Infirmary of Edinburgh — Edinburgh, United Kingdom
- University Teaching Hospital of Rwanda — Kigali, Rwanda
- Obafemi Awolowo University Teaching Hospital Complex — Ife, Nigeria
Full record on ClinicalTrials.gov
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