EICHORCondition: Surgery · Inpatients · Sponsor: University of Edinburgh
Interested? Contact the study team ↓
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 algorithm…
This description comes directly from the study's public registry record.
Ewen Harrison · +44 (0)131 651 7869 · ewen.harrison@ed.ac.uk
Eilidh Gunn · +44 (0)131 651 7869 · egunn3@ed.ac.uk
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
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| 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 |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06565559