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

Medical Device Clinical Trial

— SMART-METRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04668807
• Other study ID #: APHP190708
• Secondary ID: 2019-A02197-50
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: June 2021

Study information

• Verified date: February 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean-Louis MARTY, MD, PhD
• Phone: 01 49 81 43 45
• Email: jean.marty[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medical Device

Intervention

Device:
• Connected Medical Device
Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
• Traditional transmission system
Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - CHU Henri Mondor	Créteil

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	EVOLUCARE, InES - Innovation Electronic Software

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of missing data due to device malfunction		at 2 hours
Secondary	Nurse satisfaction (System Usability Scale)		at 2 hours
Secondary	Occurrence of events during the course of the study		at 2 hours
Secondary	Time needed by the nursing staff to set up the system		at 2 hours