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

NCT04668807 | Unknown

• 2 other identifiers: APHP1907082019-A02197-50
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Device

Keywords

Connected Medical Device; Device Feasibility; Post-operative mortality; "SMART ANGEL intra-hospital" system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Time needed by the nursing staff to set up the system

  at 2 hours

Study Arms (2)

Connected Medical Device

EXPERIMENTAL

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

Device: Connected Medical Device

Traditional system

ACTIVE COMPARATOR

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

Device: Traditional transmission system

Interventions

Connected Medical Device DEVICE

Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room

Connected Medical Device

Traditional transmission system DEVICE

Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room

Traditional system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Evolucare Technologies: collaborator
• InES - Innovation Electronic Software: collaborator

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Créteil, 94 010, France

Location

Study Officials

• Jean-Louis MARTY, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Louis MARTY, MD, PhD

CONTACT

01 49 81 43 45; jean.marty@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Measurement of 3 constants (SpO2, heart rate and respiratory rate) in patients with a non-ambulatory surgical or interventional act lasting more than 2 hours whose constants are monitored by the reference device in the operating room and the Connected Medical Device.

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: December 16, 2020
• Study Start: December 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 16, 2020

Record last verified: 2020-02

Locations

FR (1)