Substudy of MEET-OS (NCT04948632): Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices (BIOBEAT)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Surgery-Complications; Patient Satisfaction; Patient Compliance

Study type: Observational

Funder types: Other

Identifiers

NCT05686109

22.220

Details and patient eligibility

About

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.

Full description

With increasingly complex surgeries and increasingly comorbid patients, ambulatory surgery are not always at low risk of postoperative complications. Among the new support tools available for monitoring patients remotely, devices for monitoring vital signs could be of interest to healthcare staff in charge of monitoring, more precisely when comorbid patients are involved or when interventions at high risk of complications are performed.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years old undergoing elective outpatient surgery under general or regional anesthesia
• Internet access for the patient or their caregiver from home
• Written, oral and spoken comprehension of French
• Considered 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 technologies
• Conversion of ambulatory to inpatient hospitalization on the day of surgery
• Patient's refusal
• Operation performed under regional or neuraxial anesthesia alone
• Trophic skin disorders contraindicating the installation of the Biobeat® monitoring device on the torso (deformation, irritation, infection, ulceration, etc.)
• Patient with pacemaker
• MRI or CT scheduled post-operatively
• Tattoo on the torso or refusal to shave the area where the Biobeat® monitoring device should be installed
• Pregnant or breastfeeding women
• Allergy to one of the technological components

Trial design

54 participants in 1 patient group

Monitoring device Biobeat®

Description:

Biobeat® non-invasive monitoring devices can be used in an out-of-hospital perioperative setting to observe patients' vital signs up to 5 days postoperatively. The Biobeat® portable adhesive device will be installed after the surgery, in the recovery room. All patients will be equipped with a portable single-use Biobeat® Bluetooth device that will be positioned at chest level and connected via Bluetooth to the patient's cell phone. These patches have been FDA approved since 2019 (new approval in 2022) for non-invasive (systolic, diastolic, and mean) blood pressure measurement without a cuff. The following other parameters will also be recorded: peripheral oxygen saturation, heart rate, respiratory rate and body temperature based on the analysis of the plethysmography wave. This data will be recorded as soon as the patches are installed.