About this trial
Assessing the clinical and organisational impact of a home-based post-operative monitoring strategy incorporating the MultiSense® device involving 80 patients aged 65 years and over who have undergone major surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 65 or over
Patient eligible for remote monitoring using the MultiSense® device
No psychiatric illness that would prevent them from giving informed consent or receiving optimal treatment and follow-up care
Subject affiliated with a health insurance scheme
Disqualifiers
Patients already participating in an interventional clinical trial.
Patients subject to legal protection measures, guardianship, curatorship, or deprived of their liberty by judicial or administrative decision.
Patients hospitalised without consent.
Patients unable to complete a questionnaire and without a close relative to assist them in using the solution.
Trial design
Single group
Treatments tested in this trial
Monitoring by MultiSense
DeviceThe MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters
Treatment groups
Trial outcomes
Primary outcomes
The percentage of patients whose care was deemed satisfactory
The quality of surgical care will be assessed using a "textbook outcome" (TO) composed of the 2 following criteria : 1. A shorter-than-average stay (below the 75th percentile). 2. No emergency readmission or ER visit within 7 days of going home."
Secondary outcomes
Average length of initial hospital stay following surgery
Percentage of patients requiring unscheduled care related to surgery at 30 days
Patients requiring unplanned readmission and/or a visit to the emergency department
Percentage of patients with at least one unplanned rehospitalization following telemonitoring and at 30 days
Percentage of patients with at least one visit to the emergency department following telemonitoring and at day 30
Other outcomes
Temporal distribution of complications by severity level according to the Clavien-Dindo classification between the day of surgery and day 30
To assess the impact of the treatment pathway on the timing and severity of complications
Mapping of complications according to the following classification : complications of severity 1 to 2 and complications of severity 3 or higher according to the Clavien-Dindo classification at the end of remote monitoring and at day 30
To assess the impact of the treatment pathway on the timing and severity of complications
Sponsors and contacts
Click on the lead sponsor to view all of their trials.