Clinical trial NCT05686109: Substudy of MEET-OS (NCT04948632): Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices
Official title: Ancillary Study: Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices: Pilot Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery-Complications
Patient Satisfaction
Patient Compliance
Keywords: Monitoring device
Ambulatory surgery
Postoperative complications
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: HEC Montreal
First posted: 2023-01-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent an ambulatory surgery considered at high-risk of postoperative complications at the CHUM, who have accepted to be enrolled in the main study MEET-OS with two groups of patients : a group benefiting from optimized support and follow-up using the LeoMed telecare platform (Group A) and a group benefiting from the current standard of care (Group B).

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with no loss of data for a period of 2 consecutive hours over the entire follow-up period.
timeFrame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
Secondary outcomes:
measure: Percentage of useful data available per day for the interpretation of vital signs during the first 5 days
timeFrame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
measure: Percentage of patients with no data loss for 1, 4, 6, and 8 consecutive hours over the entire follow-up period.
timeFrame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
measure: Percentage of patients with data loss of one hour or more preceding a postoperative event.
timeFrame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
measure: Frequency of occurrences and the cumulative time of clinical disturbances
timeFrame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
measure: Patient's experience
timeFrame: 7 days after the surgery
measure: Percentage of appropriate and inappropriate clinical decision changes from the clinical intervention decided by the expert committee will be assessed.
timeFrame: Up to 60 days after surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Florian Robin, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: