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

Assistance Publique - Hôpitaux de Paris2,000 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

2,000

Conditions

Medical Device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.