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NCT05686109
Substudy of MEET-OS (NCT04948632): Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices
Conditions: Surgery-Complications, Patient Satisfaction, Patient Compliance
Sex: All
Ages: 18 Years – N/A
Enrollment: 50
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Location: Canada
Summary
The objective of this ancillary study of the MEET-OS study is to assess the technical feasibility of using Biobeat® monitoring devices after ambulatory surgery at high risk of complications.The secondary objectives are to assess: i) the patient's experience and tolerance ii) the occurrence of clinical disturbances in the patients's home after ambulatory surgery with high risk of postoperative complications iii) to determine the impact of the data obtained with the monitoring devices on the clinical care decisions during postoperative follow-up.
Eligibility Criteria
Inclusion Criteria:Patients over 18 years old undergoing elective outpatient surgery under general or regional anesthesiaInternet access for the patient or their caregiver from homeWritten, oral and spoken comprehension of FrenchConsidered to be at high risk of postoperative complications, defined by one of the following two criteria: an ASA 3 score or an ASA score of 2 + surgery at intermediate or high risk according to the classification of Glance and al.Exclusion Criteria:Patient's or caregiver's inability to learn and to use digital technologiesConversion of ambulatory to inpatient hospitalization on the day of surgeryPatient's refusalOperation performed under regional or neuraxial anesthesia aloneTrophic skin disorders contraindicating the installation of the Biobeat® monitoring device on the torso (deformation, irritation, infection, ulceration, etc.)Patient with pacemakerMRI or CT scheduled post-operativelyTattoo on the torso or refusal to shave the area where the Biobeat® monitoring device should be installedPregnant or breastfeeding womenAllergy to one of the technological components
Source: ClinicalTrials.gov (NCT05686109). StuddyBuddy aggregates publicly available trial information.