Medical Device
Conditions
Keywords
Connected Medical Device, Device Feasibility, Post-operative mortality, SMART ANGEL intra-hospital system
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).
Interventions
DEVICEConnected Medical Device
Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
DEVICETraditional transmission system
Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room
Sponsors
Evolucare Technologies
InES - Innovation Electronic Software
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | at 2 hours |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of missing data due to device malfunction | at 2 hours |
| Nurse satisfaction (System Usability Scale) | at 2 hours |
| Occurrence of events during the course of the study | at 2 hours |
| Time needed by the nursing staff to set up the system | at 2 hours |
Countries
France
Contacts
Primary ContactJean-Louis MARTY, MD, PhD
Outcome results
None listed