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

Not Applicable

• Conditions: Medical Device
• Interventions: Device: Connected Medical Device; Device: Traditional transmission system

• Registration Number: NCT04668807
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 a Connected Medical Device (CMD).

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-11-05
• Study Start: 2020-12
• Study First Submitted QC: 2020-12-11
• Last Update Submitted: 2020-12-11
• Study First Posted: 2020-12-16
• Last Update Posted: 2020-12-16
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Connected Medical Device	Connected Medical Device	"SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room
Traditional system	Traditional transmission system	Traditional wired transmission system between the sensor and the data processing device in the operating room

Primary Outcome Measures

Name	Time	Method
Agreement between the values measurements produced by the traditional monitoring system in the operating theater and the connected medical device of the "SMART ANGEL intra-hospital" system	at 2 hours

Secondary Outcome Measures

Name	Time	Method
Time needed by the nursing staff to set up the system	at 2 hours
Evaluation of missing data due to device malfunction	at 2 hours
Nurse satisfaction (System Usability Scale)	at 2 hours
Occurrence of events during the course of the study	at 2 hours

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor; 🇫🇷 Créteil, France