Overview
The SENSE-ECO study is a prospective, randomized trial of 490 high-risk patients designed to show that the MultiSense® remote monitoring patch safely reduces hospital stays following major digestive surgery. By continuously tracking vital signs for five days at home, the device aims to maintain clinical safety and quality of life while decreasing overall healthcare costs for the French medical system.
Description
SENSE-ECO study is a prospective, multicenter, randomized open-label trial designed to evaluate the clinical and medico-economic impact of the MultiSense® remote monitoring solution for 490 high-risk patients (ASA 2 or 3) undergoing major digestive surgery. The primary objective is to demonstrate that using this Class IIa wearable patch to monitor vital signs-such as heart rate, $SpO\_2$, and respiratory rate-allows for a reduced initial hospital stay without increasing 30-day morbidity compared to standard care. In the experimental group, patients are equipped with the device 12 to 24 hours before discharge to continue continuous home monitoring for five days, while the study also assesses secondary factors including cost-effectiveness for the French healthcare system, patient quality of life via the fQoR-15 questionnaire, and organizational workload for medical staff. Conducted across five centers under the coordination of Dr. Ugo Marchese.
Eligibility
Inclusion Criteria :
- Adults (aged 18 and over)
- Patients scheduled for gastrointestinal surgery :
- Major gastrointestinal cancer surgery (pancreas, liver, stomach, oesophagus, rectum)
- Colorectal surgery (rectal resection, surgery on the rectum and anus other than rectal resection, minor or major surgery on the small intestine and colon)
- Patients in non-critical care with a high risk of post-surgical complications (ASA score 2 or 3)
- Patients who have a personal mobile phone and Wi-Fi connectivity at home
- Patients who provide written informed consent to participate in the study
- Patients who are members of or beneficiaries of a social security scheme
- Patients who are proficient in French
Exclusion Criteria :
- Patients with a contraindication to the use of the device as described in the instructions for use (in particular: known skin allergy to adhesives or silicone, active implantable medical device such as a pacemaker or defibrillator, need for an MRI scan during the intended use of the device, intended application site of the device being tattooed, infected, ulcerated or damaged)
- Any other condition which, in the investigator's opinion, would compromise the patient's safety or prevent compliance with the requirements of the protocol
- Pregnant or breastfeeding patient
- Adult under legal protection (under guardianship, curatorship or judicial protection)
- Patient already participating in a clinical trial
