NCT06565559 EMUs: Enhanced Monitoring Using Sensors After Surgery
| NCT ID | NCT06565559 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,332 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,332 participants in total. It began in 2024-02-28 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
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.
Contact & Investigator
Ewen Harrison
PRINCIPAL INVESTIGATOR
University of Edinburgh
Frequently Asked Questions
Who can join the NCT06565559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06565559 currently recruiting?
Yes, NCT06565559 is actively recruiting participants. Contact the research team at ewen.harrison@ed.ac.uk for enrollment information.
Where is the NCT06565559 trial being conducted?
This trial is being conducted at Ouidah, Benin, Parakou, Benin, Cotonou, Benin, Porto-Novo, Benin and 11 additional locations.
Who is sponsoring the NCT06565559 clinical trial?
NCT06565559 is sponsored by University of Edinburgh. The principal investigator is Ewen Harrison at University of Edinburgh. The trial plans to enroll 1,332 participants.