RecruitingNCT06565559

EMUs: Enhanced Monitoring Using Sensors After Surgery


Sponsor

University of Edinburgh

Enrollment

1,332 participants

Start Date

Feb 28, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria4

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

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Interventions

DEVICEWearable Wireless Sensor

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.


Locations(17)

Hopital de Zone Atlantique Ouidah

Ouidah, Atlantique Department, Benin

Centre Hospitalier Universitaire Departemental Borgou-Alibori

Parakou, Borgou Department, Benin

Centre Hospitalier Universitaire Mere Enfant Lagune

Cotonou, Littoral Department, Benin

Centre Hospitalier Universitaire et Departemental Oueme Plateau

Porto-Novo, Oeume, Benin

Berekum Holy Family Hospital

Berekum, Berekum East, Ghana

Techiman Holy Family Hospital

Techiman, Bono East, Ghana

Tamale Teaching Hospital

Tamale, Ghana

Hospital General San Juan de Dios

Guatemala City, Guatemala

Lady Willingdon Hospital

Manali, Himachal Pradesh, India

Padhar Hospital

Pādhar, Madhya Pradesh, India

Christian Medical College and Hospital

Ludhiana, Punjab, India

Hospital Español de Veracruz

Veracruz, Mexico

Obafemi Awolowo University Teaching Hospital Complex

Ife, Nigeria

Lagos State University Teaching Hospital

Ikeja, Nigeria

Lagos University Teaching Hospital

Lagos, Nigeria

University Teaching Hospital of Rwanda

Kigali, Rwanda

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

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