Status:
UNKNOWN
Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Evolucare Technologies
InES - Innovation Electronic Software
Conditions:
Medical Device
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies. Complicat...
Detailed Description
The challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple pa...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- 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
- Patient carrying a multi-resistant germ and placed in isolation
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04668807
Start Date
December 1 2020
End Date
June 1 2021
Last Update
December 16 2020
Active Locations (1)
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1
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, France, 94 010