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

Medical Device Clinical Trial

— SMARTANGEL  

Official title:

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 )

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05380310
• Other study ID #: APHP210932
• Secondary ID: N° IDRCB
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2022
• 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 the "SMART ANGEL Intra-hospital" System's (connected medical devices and alerts).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medical Device

Intervention

Device:
• Active "SMART ANGEL" solution
Nurse intervention according to the alert level + traditional monitoring
• Inactive "SMART ANGEL" solution
No alert + traditional monitoring + alert in case of imminent life threat

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