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

NCT05686109 | Completed

• 1 other identifier: 22.220
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery-Complications; Patient Satisfaction; Patient Compliance

Keywords

Monitoring device; Ambulatory surgery; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with no loss of data for a period of 2 consecutive hours over the entire follow-up period.

  From the installation of the monitoring device after the surgery up to 5 days postoperatively.

Secondary Outcomes (6)

• Percentage of useful data available per day for the interpretation of vital signs during the first 5 days

  From the installation of the monitoring device after the surgery up to 5 days postoperatively.

• Percentage of patients with no data loss for 1, 4, 6, and 8 consecutive hours over the entire follow-up period.

  From the installation of the monitoring device after the surgery up to 5 days postoperatively.

• Percentage of patients with data loss of one hour or more preceding a postoperative event.

  From the installation of the monitoring device after the surgery up to 5 days postoperatively.

• Frequency of occurrences and the cumulative time of clinical disturbances

  From the installation of the monitoring device after the surgery up to 5 days postoperatively.

• Patient's experience

  7 days after the surgery

Study Arms (1)

Monitoring device Biobeat®

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• HEC Montreal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

Location

MeSH Terms

Conditions

Patient Satisfaction; Patient Compliance; Postoperative Complications

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Florian Robin, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: February 21, 2023
• Primary Completion: August 11, 2023
• Study Completion: August 18, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)