Medical Device
Conditions
Keywords
Connected Medical Device, Time to diagnosis, 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 the SMART ANGEL Intra-hospital System's (connected medical devices and alerts).
Interventions
DEVICEActive SMART ANGEL solution
Nurse intervention according to the alert level + traditional monitoring
DEVICEInactive SMART ANGEL solution
No alert + traditional monitoring + alert in case of imminent life threat
Sponsors
Evolucare Technologies
InES - Innovation Electronic Software
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in response times for nurses | between inclusion visit and day 30 | Difference in response times between the two groups as measured by the difference between the exact time of occurrence of the complication and the time of caregiver intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality within 30 days of surgery | between inclusion visit and day 30 | — |
| Percentage of transfers to intensive care unit | between inclusion visit and day 30 | — |
| Length of stay | between inclusion visit and day 30 | — |
| ICU length of stay | between inclusion visit and day 30 | — |
| Rate of calls to the doctor on duty | between inclusion visit and day 30 | — |
| Percentage of re-hospitalization within 30 days | between inclusion visit and day 30 | — |
| Mortality during hospitalisation | between inclusion visit and day 30 | Within 30 days of the intervention |
| Percentage of patients managed at home | between inclusion visit and day 30 | — |
| False positive rate | between inclusion visit and day 30 | Alert without complication for the patient |
| Incremental cost-effectiveness ratio | between inclusion visit and day 30 | — |
| Patient acceptability | between inclusion visit and day 30 | Quantitative and qualitative assessment of the device's usability by the patient via Questionnaire and interview |
| Acceptability of care teams | between inclusion visit and day 30 | Questionnaire and interview |
| Percentage of hospitalisations in follow-up care and rehabilitation care units | between inclusion visit and day 30 | — |
Countries
France
Contacts
Primary ContactJean-Louis MARTY, MD,PHD
Outcome results
None listed