Validation of a Connected Patch, an Alternative to Conventional Monitoring

NCT ID: NCT04053179

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-09-04

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 Scaléo Médical 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 Scaléo Médical's connected patch in different locations: post-interventional surveillance room that approaches a conventional hospital room, operating room where artifacts are numerous.

Conditions

Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Connected patch validation

Group Type: EXPERIMENTAL

Patch validation

Intervention Type: DEVICE

Use of connected patch to collect blood pressure, heart rate, respiratory rate, arterial oxygen saturation and temperature

Interventions

Patch validation

Use of connected patch to collect blood pressure, heart rate, respiratory rate, arterial oxygen saturation and temperature

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morgan Le Guen

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Locations

Hôpital Foch

Suresnes, , France

Countries

France

Other Identifiers

2017055F

Identifier Type: -

Identifier Source: org_study_id