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

Patient Satisfaction Clinical Trial

— BIOBEAT  

Official title:

Ancillary Study: Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices: Pilot Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686109
• Other study ID #: 22.220
• Status: Completed
• Start date: February 21, 2023
• Est. completion date: August 18, 2023

Study information

• Verified date: September 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 18, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Compliance
• Patient Satisfaction

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	HEC Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Percentage of patients with data loss of one hour or more preceding a postoperative event.	The postoperative event is defined as a call to the CHUM health info line.	From the installation of the monitoring device after the surgery up to 5 days postoperatively.
Secondary	Frequency of occurrences and the cumulative time of clinical disturbances	The occurrence of manufacturer alerts and the following clinical disturbances within 72 hours postoperatively will be evaluated: moderate postoperative arterial hypotension (defined by mean arterial pressure < 65 mmHg), severe arterial hypotension defined by MAP < 60 mmHg; moderate arterial hypertension defined by an MAP > 110mmHg; severe arterial hypertension defined by a MAP > 130mmHg; bradycardia defined by a heart rate < 40bpm; tachycardia defined by a heart rate > 100bpm; bradypnea defined by respiratory rate < 8/min; tachypnea defined by respiratory rate > 20/min; oxygen desaturation < 95%; oxygen desaturation < 90%; oxygen desaturation < 85%; hypothermia defined as body temperature < 36.0°C; hyperthermia defined as body temperature > 38.0°C.	From the installation of the monitoring device after the surgery up to 5 days postoperatively.
Secondary	Patient's experience	A phone interview will be conducted to collect the patient's experience with a questionnaire derived from Breteler and al., which consist of 12 questions, adapted to the present study and focused on the experience of the patient and his caregiver, his tolerance and his satisfaction.	7 days after the surgery
Secondary	Percentage of appropriate and inappropriate clinical decision changes from the clinical intervention decided by the expert committee will be assessed.		Up to 60 days after surgery