Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD)
NCT ID: NCT04668807
Last Updated: 2020-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-12-31
2021-06-30
Brief Summary
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Complications due to the medical practice are the third cause of morbidity(BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure.
Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Connected Medical Device
"SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room
Connected Medical Device
Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
Traditional system
Traditional wired transmission system between the sensor and the data processing device in the operating room
Traditional transmission system
Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room
Interventions
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Connected Medical Device
Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
Traditional transmission system
Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room
Eligibility Criteria
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Inclusion Criteria
* Patients receiving a non-ambulatory surgical or interventional procedure lasting more than 2 hours
* Affiliation with a social security syste, beneficiarie or eligible people (excluding State Medical Assistance (AME))
* Written consent of the patient
Exclusion Criteria
* Patient's known linguistic inability to understand the study
* Non-ambulatory surgical or interventional act in an emergency situation
* Patients under legal protection : curatorship or guardianship
* Known pregnancy or nursing woman
* Patients with implantable cardiac pacemakers, implantable defibrillators or neurostimulators
18 Years
ALL
No
Sponsors
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Evolucare Technologies
INDUSTRY
InES - Innovation Electronic Software
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Louis MARTY, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Jean-Louis MARTY, MD, PhD
Role: primary
Other Identifiers
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2019-A02197-50
Identifier Type: OTHER
Identifier Source: secondary_id
APHP190708
Identifier Type: -
Identifier Source: org_study_id