Clinical trial NCT04668807: Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD)
Official title: Assessment of the Technical Capabilities of the "SMART ANGEL" Intra-hospital System 's Connected Medical Device (CMD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medical Device
Keywords: Connected Medical Device
Device Feasibility
Post-operative mortality
"SMART ANGEL intra-hospital" system
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Evolucare Technologies
name: InES - Innovation Electronic Software
First posted: 2020-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Measurement of 3 constants (SpO2, heart rate and respiratory rate) in patients with a non-ambulatory surgical or interventional act lasting more than 2 hours whose constants are monitored by the reference device in the operating room and the Connected Medical Device.
Primary purpose: DEVICE_FEASIBILITY

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.

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: 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 parameters using a Connected Medical Device (CMD).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Agreement between the values measurements produced by the traditional monitoring system in the operating theater and the connected medical device of the "SMART ANGEL intra-hospital" system
timeFrame: at 2 hours
Secondary outcomes:
measure: Evaluation of missing data due to device malfunction
timeFrame: at 2 hours
measure: Nurse satisfaction (System Usability Scale)
timeFrame: at 2 hours
measure: Occurrence of events during the course of the study
timeFrame: at 2 hours
measure: Time needed by the nursing staff to set up the system
timeFrame: at 2 hours
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Louis MARTY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: