Validation of a Connected Patch, an Alternative to Conventional Monitoring (Patch)

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.

Study Overview

• Status: Withdrawn
• Conditions: Anesthesia
• Intervention / Treatment: Device: Patch validation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Publications and helpful links

General Publications

• Le Guen M, Squara P, Ma S, Adjavon S, Trillat B, Merzoug M, Aegerter P, Fischler M. Patch validation: an observational study protocol for the evaluation of a multisignal wearable sensor in patients during anaesthesia and in the postanaesthesia care unit. BMJ Open. 2020 Sep 25;10(9):e040453. doi: 10.1136/bmjopen-2020-040453.

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Anticipated): May 29, 2022
• Study Completion (Anticipated): June 3, 2022

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 11, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be available in the Dryad repository
• IPD Sharing Time Frame: After publication in a peer-review journal .No limit in time
• IPD Sharing Access Criteria: No criteria
• IPD Sharing Supporting Information Type: Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No