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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Medical Device

Treatments: Device: Active "SMART ANGEL" solution; Device: Inactive "SMART ANGEL" solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05380310

APHP210932

N° IDRCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,000 participants in 2 patient groups

Active alerts

Experimental group

Description:

"SMART ANGEL Intra-hospital" System with active alerts

Treatment:

Device: Active "SMART ANGEL" solution

Inactive alerts

Active Comparator group

Description:

"SMART ANGEL Intra-hospital" System with inactive alerts

Treatment:

Device: Inactive "SMART ANGEL" solution