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Validation of a Connected Patch, an Alternative to Conventional Monitoring

Validation of a Connected Patch, an Alternative to Conventional Monitoring

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04053179
Enrollment
0
Registered
2019-08-12
Start date
2020-01-01
Completion date
2020-09-04
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

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

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Concordance of blood pressure value measured by 2 different devices after surgery36 hours maximum after the surgeryComparison between blood pressure measured by conventional medical monitoring device and by connected patch
Concordance of heart rate value measured by 2 different devices after surgery36 hours maximum after the surgeryComparison between heart rate measured by conventional medical monitoring device and by connected patch
Concordance of respiratory rate value measured by 2 different devices after surgery36 hours maximum after the surgeryComparison between respiratory rate measured by conventional medical monitoring device and by connected patch
Concordance of arterial oxygen saturation value measured by 2 different devices after surgery36 hours maximum after the surgeryComparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
Concordance of temperature value measured by 2 different devices after surgery36 hours maximum after the surgeryComparison between temperature measured by conventional medical monitoring device and by connected patch

Secondary

MeasureTime frameDescription
Blood pressure artifactFrom surgery to 36 hours maximum after the surgeryValue of blood pressure will be considered as artifact if systolic blood pressure value \< 80 or \> 200 and diastolic blood pressure \> 110
Heart rate artifactFrom surgery to 36 hours maximum after the surgeryValue of heart rate will be considered as artifact if value \< 40 or \> 140
Concordance of blood pressure value measured by 2 different devices during surgeryDuring surgeryComparison between blood pressure measured by conventional medical monitoring device and by connected patch
Arterial oxygen saturation artifactFrom surgery to 36 hours maximum after the surgeryValue of arterial oxygen saturation will be considered as artifact if value \< 85 %
Acceptability of connected patch: numerical scaleDuring the surgery and through study completionEvaluation of connected patch with a simple numerical scale between 0 and 10: 0 representing a very poor tolerance of the device and leading to premature interruption of the collection and 10 a perfect tolerance allowing the patch to be maintained for several consecutive days
Respiratory rate artifactFrom surgery to 36 hours maximum after the surgeryValue of respiratory rate will be considered as artifact if value \< 8 or \> 36
Concordance of heart rate value measured by 2 different devices during surgeryDuring surgeryComparison between heart rate measured by conventional medical monitoring device and by connected patch
Concordance of respiratory rate value measured by 2 different devices during surgeryDuring surgeryComparison between respiratory rate measured by conventional medical monitoring device and by connected patch
Concordance of arterial oxygen saturation value measured by 2 different devices during surgeryDuring surgeryComparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
Concordance of temperature value measured by 2 different devices during surgeryDuring surgeryComparison between temperature value measured by conventional medical monitoring device and by connected patch

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026