Validation of a Connected Patch, an Alternative to Conventional Monitoring

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.

Detailed Description
-----------------
When patients operated on outside intensive care or intensive care units are hospitalized, vital signs are collected intermittently by various conventional devices. During the follow-up period of these patients, it is possible that abnormal vital signs that may identify clinical deterioration may appear a few minutes to a few hours before a serious adverse event (infection etc.) occurs. These signals often go unnoticed due to infrequent monitoring. The establishment of teams to ensure a rapid response would improve the safety of hospitalized patients for whom the detection of abnormal vital signs predictive of clinical deterioration would generate an alarm. This system is based on the identification of patients at risk and the rapid intervention of the team. One of the crucial issues is therefore the speed of the alarm and its reliability. The evolution of electronic technology offers the possibility of using inexpensive portable devices (connected patches) that can provide information on vital signs in real time. Vital signs collected by these devices could be analyzed to predict clinical deterioration prior to hospital staff visits, especially at night and on weekends when staffing levels are generally lower. The connected patch used in this research is the Devinnova company's device myAngel VitalSigns. The long-term objective would be to be able to use this connected patch in surgical departments to detect early a complication, particularly of a cardiovascular or respiratory nature, and therefore to treat it without wasting time. However, it has not been validated in a hospital setting; that is the purpose of the project. The objective of this research is therefore to validate Devinnova's connected patch in different locations: post-interventional surveillance room that approaches a conventional hospital room, operating room where artifacts are numerous.

Official Title
-----------------
Validation of a Connected Patch, an Alternative to Conventional Monitoring

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: Patch validation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient over 18 and under 85 years of age patient requiring general anesthesia for extra-thoracic surgery the patient's position during the operation is in supine position only patient affiliated to or benefiting from social security, excluding State Medical Assistance patient with written consent Exclusion Criteria: pregnant or breastfeeding patients patients known to have severe skin reactions to adhésives patient whose surgical procedure prevents the patch from being placed (intervention on the thorax) patients deprived of their liberty or under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Connected patch validation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connected patch validation<br> | Device: Patch validation<br>* Use of connected patch to collect blood pressure, heart rate, respiratory rate, arterial oxygen saturation and temperature<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of blood pressure value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit | Comparison between blood pressure measured by conventional medical monitoring device and by connected patch | 36 hours maximum after the surgery | 
| Concordance of heart rate value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit | Comparison between heart rate measured by conventional medical monitoring device and by connected patch | 36 hours maximum after the surgery | 
| Concordance of respiratory rate value measured by 2 different during the postoperative stay in the post-operative period in the post-anesthesia care unit | Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch | 36 hours maximum after the surgery | 
| Concordance of arterial oxygen saturation value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia | Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch | 36 hours maximum after the surgery | 
| Concordance of temperature value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit | Comparison between temperature measured by conventional medical monitoring device and by connected patch | 36 hours maximum after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of blood pressure value measured by 2 different devices during anesthesia | Comparison between blood pressure measured by conventional medical monitoring device and by connected patch | During anesthesia | 
| Concordance of heart rate value measured by 2 different devices during anesthesia | Comparison between heart rate measured by conventional medical monitoring device and by connected patch | During anesthesia | 
| Concordance of respiratory rate value measured by 2 different devices during anesthesia | Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch | During anesthesia | 
| Concordance of arterial oxygen saturation value measured by 2 different devices during anesthesia | Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch | During anesthesia | 
| Concordance of temperature value measured by 2 different devices during anesthesia | Comparison between temperature value measured by conventional medical monitoring device and by connected patch | During anesthesia | 
| Blood pressure artifact | An artifact is defined as any value that deviates from a physiologically plausible range or by a deviation > 50% from the previous value unless this value is followed by a value equal to ± 25% | From beginning of anesthesia to 36 hours | 
| Heart rate artifact | An artifact is defined as any value that deviates from a physiologically plausible range or by a deviation > 50% from the previous value unless this value is followed by a value equal to ± 25% | From beginning of anesthesia to 36 hours maximum after the surgery | 
| Respiratory rate artifact | An artifact is defined as any value that deviates from a physiologically plausible range or by a deviation > 50% from the previous value unless this value is followed by a value equal to ± 25% | From beginning of anesthesia to 36 hours maximum after the surgery | 
| Arterial oxygen saturation artifact | An artifact is defined as any value that deviates from a physiologically plausible range or by a deviation > 50% from the previous value unless this value is followed by a value equal to ± 25% | From beginning of anesthesia to 36 hours maximum after the surgery | 
| Acceptability of connected patch | The patient will be asked to evaluate its acceptance of the sensor using a 4-point Likert scale (from 0 = intolerable to 4 = no problem at all) | During the surgery and 36 hours maximum after the surgery |