Status:
UNKNOWN
Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device
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 scheduled non-ambulatory surgical or interventional procedure
- Affiliation to a social security scheme, beneficiary or entitled person (excluding AME)
- Patient's written consent or of the trusted person in case of physical incapacity
Exclusion
- Inclusion in emergency situations
- ASA1 patient (without associated pathology)
- Patient with a multi-drug resistant germ in isolation
- Known linguistic inability of the patient to understand the study
- Known pregnancy or breastfeeding woman
- Patients with implantable pacemakers, implantable defibrillators or neurostimulators.
- Person under legal protection or unable to give consent
- Person deprived of liberty by judicial or administrative decision
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05380310
Start Date
June 1 2022
End Date
July 1 2023
Last Update
May 18 2022
Active Locations (1)
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1
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, France, 94010