Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD) (SMART-METRO)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Medical Device

Treatments: Device: Traditional transmission system; Device: Connected Medical Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04668807

2019-A02197-50 (Other Identifier)

APHP190708

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 a Connected Medical Device (CMD).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Connected Medical Device

Experimental group

Description:

"SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room

Treatment:

Device: Connected Medical Device

Traditional system

Active Comparator group

Description:

Traditional wired transmission system between the sensor and the data processing device in the operating room

Treatment:

Device: Traditional transmission system