SMARTANGEL: Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05380310

Collaborator

EVOLUCARE (Other), InES - Innovation Electronic Software (Other)

2,000

Enrollment

Location

Arms

Anticipated Duration (Months)

154.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medical Device	Device: Active "SMART ANGEL" solution Device: Inactive "SMART ANGEL" solution	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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 )

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active alerts "SMART ANGEL Intra-hospital" System with active alerts	Device: Active "SMART ANGEL" solution Nurse intervention according to the alert level + traditional monitoring
Active Comparator: Inactive alerts "SMART ANGEL Intra-hospital" System with inactive alerts	Device: Inactive "SMART ANGEL" solution No alert + traditional monitoring + alert in case of imminent life threat

Arm

Intervention/Treatment

Experimental: Active alerts

"SMART ANGEL Intra-hospital" System with active alerts

Device: Active "SMART ANGEL" solution

Nurse intervention according to the alert level + traditional monitoring

Active Comparator: Inactive alerts

"SMART ANGEL Intra-hospital" System with inactive alerts

Device: Inactive "SMART ANGEL" solution

No alert + traditional monitoring + alert in case of imminent life threat

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Mortality during hospitalisation [between inclusion visit and day 30]
Within 30 days of the intervention
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]
Percentage of hospitalisations in follow-up care and rehabilitation care units [between inclusion visit and day 30]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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