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

Impact on the Time to Diagnosis of Serious Post-operative Complications of Continuous, Individualised, Alert Monitoring of SpO2, Heart Rate and Respiratory Rate by a Controlled Connected Medical Device (SMART ANGEL Intra )

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Medical Device
• Intervention / Treatment: Device: Active "SMART ANGEL" solution; Device: Inactive "SMART ANGEL" solution

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 the "SMART ANGEL Intra-hospital" System's (connected medical devices and alerts).

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Louis MARTY, MD,PHD; Phone Number: +33 01 49 81 43 45; Email: jean.marty@aphp.fr

Study Locations

• France
  • Créteil, France, 94010
    • Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
    • Contact: Jean-Louis MARTY, MD,PHD; Phone Number: +33 01 49 81 43 45; Email: jean.marty@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active alerts; "SMART ANGEL Intra-hospital" System with active alerts	Device: Active "SMART ANGEL" solution; Nurse intervention according to the alert level + traditional monitoring
Active Comparator: Inactive alerts; "SMART ANGEL Intra-hospital" System with inactive alerts	Device: Inactive "SMART ANGEL" solution; No alert + traditional monitoring + alert in case of imminent life threat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in response times for nurses	Difference in response times between the two groups as measured by the difference between the exact time of occurrence of the complication and the time of caregiver intervention.	between inclusion visit and day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality during hospitalisation	Within 30 days of the intervention	between inclusion visit and day 30
Mortality within 30 days of surgery		between inclusion visit and day 30
Percentage of transfers to intensive care unit		between inclusion visit and day 30
Length of stay		between inclusion visit and day 30
ICU length of stay		between inclusion visit and day 30
Rate of calls to the doctor on duty		between inclusion visit and day 30
Percentage of re-hospitalization within 30 days		between inclusion visit and day 30
Percentage of hospitalisations in follow-up care and rehabilitation care units		between inclusion visit and day 30
Percentage of patients managed at home		between inclusion visit and day 30
False positive rate	Alert without complication for the patient	between inclusion visit and day 30
Incremental cost-effectiveness ratio		between inclusion visit and day 30
Patient acceptability	Quantitative and qualitative assessment of the device's usability by the patient via Questionnaire and interview	between inclusion visit and day 30
Acceptability of care teams	Questionnaire and interview	between inclusion visit and day 30

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Evolucare Technologies; InES - Innovation Electronic Software
• Investigators: Study Director: Jean-Louis MARTY, MD,PHD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Time to diagnosis; Connected Medical Device; Post-operative mortality; "SMART ANGEL intra-hospital" system
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Pharmaceutical Solutions
• Other Study ID Numbers: APHP210932; N° IDRCB (Other Identifier: 2025-A01594-45)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No