Clinical trial NCT04344093: Validation of a Connected Patch, an Alternative to Conventional Monitoring
Official title: Validation of a Connected Patch, an Alternative to Conventional Monitoring
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Connected patch validation
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 36 hours maximum after the surgery
measure: 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
timeFrame: 36 hours maximum after the surgery
measure: Concordance of respiratory rate value measured by 2 different during the postoperative stay in the post-operative period in the post-anesthesia care unit
timeFrame: 36 hours maximum after the surgery
measure: Concordance of arterial oxygen saturation value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia
timeFrame: 36 hours maximum after the surgery
measure: Concordance of temperature value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit
timeFrame: 36 hours maximum after the surgery
Secondary outcomes:
measure: Concordance of blood pressure value measured by 2 different devices during anesthesia
timeFrame: During anesthesia
measure: Concordance of heart rate value measured by 2 different devices during anesthesia
timeFrame: During anesthesia
measure: Concordance of respiratory rate value measured by 2 different devices during anesthesia
timeFrame: During anesthesia
measure: Concordance of arterial oxygen saturation value measured by 2 different devices during anesthesia
timeFrame: During anesthesia
measure: Concordance of temperature value measured by 2 different devices during anesthesia
timeFrame: During anesthesia
measure: Blood pressure artifact
timeFrame: From beginning of anesthesia to 36 hours
measure: Heart rate artifact
timeFrame: From beginning of anesthesia to 36 hours maximum after the surgery
measure: Respiratory rate artifact
timeFrame: From beginning of anesthesia to 36 hours maximum after the surgery
measure: Arterial oxygen saturation artifact
timeFrame: From beginning of anesthesia to 36 hours maximum after the surgery
measure: Acceptability of connected patch
timeFrame: During the surgery and 36 hours maximum after the surgery
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital FOCH
Study officials:
affiliation: Hopital Foch
name: Marc FISCHLER, MD
role: STUDY_CHAIR
References:
citation: 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.