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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-07-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Medical Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active alerts

"SMART ANGEL Intra-hospital" System with active alerts

Group Type EXPERIMENTAL

Active "SMART ANGEL" solution

Intervention Type DEVICE

Nurse intervention according to the alert level + traditional monitoring

Inactive alerts

"SMART ANGEL Intra-hospital" System with inactive alerts

Group Type ACTIVE_COMPARATOR

Inactive "SMART ANGEL" solution

Intervention Type DEVICE

No alert + traditional monitoring + alert in case of imminent life threat

Interventions

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Active "SMART ANGEL" solution

Nurse intervention according to the alert level + traditional monitoring

Intervention Type DEVICE

Inactive "SMART ANGEL" solution

No alert + traditional monitoring + alert in case of imminent life threat

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No