Clinical trial NCT05380310: Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device
Official title: Impact on the Time to Diagnosis of Serious Post-operative Complications of Continuous, Individualised, Alert Monitoring of SpO2, Heart Rate and Respiratory Rate by a Controlled Connected Medical Device (SMART ANGEL Intra )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medical Device
Keywords: Connected Medical Device
Time to diagnosis
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: 2022-05-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Difference in response times for nurses
timeFrame: between inclusion visit and day 30
Secondary outcomes:
measure: Mortality during hospitalisation
timeFrame: between inclusion visit and day 30
measure: Mortality within 30 days of surgery
timeFrame: between inclusion visit and day 30
measure: Percentage of transfers to intensive care unit
timeFrame: between inclusion visit and day 30
measure: Length of stay
timeFrame: between inclusion visit and day 30
measure: ICU length of stay
timeFrame: between inclusion visit and day 30
measure: Rate of calls to the doctor on duty
timeFrame: between inclusion visit and day 30
measure: Percentage of re-hospitalization within 30 days
timeFrame: between inclusion visit and day 30
measure: Percentage of hospitalisations in follow-up care and rehabilitation care units
timeFrame: between inclusion visit and day 30
measure: Percentage of patients managed at home
timeFrame: between inclusion visit and day 30
measure: False positive rate
timeFrame: between inclusion visit and day 30
measure: Incremental cost-effectiveness ratio
timeFrame: between inclusion visit and day 30
measure: Patient acceptability
timeFrame: between inclusion visit and day 30
measure: Acceptability of care teams
timeFrame: between inclusion visit and day 30
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: STUDY_DIRECTOR
References: