Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1332 participants
OBSERVATIONAL
2024-02-28
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission
NCT05536206
Hospital Based Continuous Patient Monitoring System
NCT06739447
Suitability of Unobtrusive Bed Monitoring and Wrist-worn Heart Rate Monitor for Patient Monitoring
NCT03572751
Home Monitoring for Thoracic Surgery Patients
NCT04340960
Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management
NCT04686526
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study has three objectives which will be addressed in three stages.
STAGE 1. Usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment.
STAGE 2. Baseline postoperative monitoring practice assessment and device usability testing in clinical environment.
STAGE 3. Shadow-mode cohort study with collection of time-stamped sensor and clinical event data to determine relationships between physiological waveforms and patient deterioration.
This registration focuses on the shadow-mode cohort study.
This study will be performed in departments of general surgery in Benin, Ghana, Guatemala, India, Mexico, Nigeria, Rwanda, and the UK. In Stages 2 and 3, patients will have undergone major surgery and will be recovering in postoperative wards.
This study can be performed using any suitable wearable device (it is device agnostic), as it seeks to gather generalisable information. In the first instance, the Sibel ANNE® One device will be used. ANNE® One is a wireless ICU-grade dual sensor system that provides real-time physiological monitoring. The system features two skin-mounted, bio-integrated sensors that provide continuous storage of vital sign measurements and physiological waveforms.
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. True equipoise exists: it is not clear whether these data are useful or how they should be used. Patients will be managed with standard care throughout.
Wearable sensors have potential application in improving postoperative monitoring and consequently, the reduction of avoidable morbidity and mortality. Sensor data may be used to generate prediction algorithms providing a continuous readout of individual patient risk. Such algorithms could enhance healthcare workers' capacity to identify and intervene upon patients with early complications. However, few high-quality studies have yet been performed in this area.
This study has approvals form the following ethical review boards:
Edinburgh Medical School Research Ethics Committee West of Scotland Research Ethics Service (on behalf of NHS Health Research Authority) Health and Care Research Wales (on behalf of NHS Health Research Authority) Ghana Health Service Ethics Review Committee Comite de Investigacion, Hospital General San Juan de Dios, Guatemala, Guatemala Christian Medical College and Hospital, Institutional Ethics Committee, Ludhiana, India El Comite de Etica en Investigacion del Hospital General de Boca del Rio, Veracruz, Mexico Lagos University Teaching Hospital Health Research Ethics Committee, Lagos Nigeria Lagos State University Teaching Hospital Health Research Ethics Committee, Ikeja, Nigeria Obafemi Awolowo University Hospitals Teaching Complex, Ethics and Research Committee, Ife, Nigeria Ethics Committee of University Teaching Hospital of Kigali, Kigali, Rwanda
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study Cohort
All surgical patients that fit the study eligibility criteria.
Wearable 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Wearable 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* A documented or suspected allergy to adhesive dressings.
* Obstetric patients
* Unwilling or unable to provide written informed consent.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Birmingham
OTHER
University for Development Studies, Tamale, Ghana
OTHER
Hospital San Juan de Dios Guatemala
OTHER_GOV
Christian Medical College and Hospital, Ludhiana, India
OTHER
Hospital Español de Veracruz, Veracruz, Mexico
UNKNOWN
University of Rwanda
OTHER
University of Lagos, Nigeria
OTHER
School of health sciences, University of Abomey Calavi, Benin
UNKNOWN
University of Edinburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ewen Harrison
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Burke JR, Downey C, Almoudaris AM. Failure to Rescue Deteriorating Patients: A Systematic Review of Root Causes and Improvement Strategies. J Patient Saf. 2022 Jan 1;18(1):e140-e155. doi: 10.1097/PTS.0000000000000720.
Ghaferi AA, Birkmeyer JD, Dimick JB. Variation in hospital mortality associated with inpatient surgery. N Engl J Med. 2009 Oct 1;361(14):1368-75. doi: 10.1056/NEJMsa0903048.
Jiwa A, Cameron MM, Ademuyiwa AO, Adisa A, Aguilera Arevalo ML, Bahrami Hessari M, Bhangu A, Brennan PM, Clark N, Cresswell K, Czerwinska I, D'Adderio L, Gunn E, Haque PD, Ikegwuonu T, Lawani I, Morton D, Nganwa A, Ntirenganya F, Pius R, Ramos de la Medina A, Samuel S, Shaw CA, Tabiri S, Townsend RC, Varghese C, Ghosh D, Harrison EM; NIHR Global Health Research Unit on Global Surgery. Continuous physiological monitoring for the detection of postoperative deterioration: a protocol for a multistage, multicentre, international, prospective cohort study. BMJ Open. 2025 Oct 6;15(10):e104463. doi: 10.1136/bmjopen-2025-104463.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13344828
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EMUs
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.