Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
EMUs Enhanced Monitoring Using Sensors After Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EMUs Enhanced Monitoring Using Sensors After Surgery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMUs
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
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
Detailed Description:
Patients who die after surgery frequently have treatable complications which are not identified in a timely manner This is due to a failure to recognize relay or react to the deterioration of a patient in the postoperative period This study aims to determine whether data from wearable physiological monitors can be used for the early detection of patient deterioration while being acceptable to patients and healthcare staff If found useful future studies would be conducted to determine the performance and safety of such a device
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None