Surgery-ComplicationsBIOBEATNCT05686109
Substudy of MEET-OS (NCT04948632): Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices
An observational study of Surgery-Complications and Patient Satisfaction, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery-Complications, Patient Satisfaction, Patient Compliance
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 21 Feb 2023to 18 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1
About this study
Official title: Ancillary Study: Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices: Pilot Feasibility Study
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.
Read the 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.
- Keywords
- Monitoring device, Ambulatory surgery, Postoperative complications
- Medical subject headings
- Patient Satisfaction, Patient Compliance, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with no loss of data for a period of 2 consecutive hours over the entire follow-up period.
Measured: 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
Measured: 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.
Measured: 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.
The postoperative event is defined as a call to the CHUM health info line.
Measured: 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
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.
Measured: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
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.
Measured: 7 days after the surgery
Percentage of appropriate and inappropriate clinical decision changes from the clinical intervention decided by the expert committee will be assessed.
Measured: Up to 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start21 Feb 2023
- Primary completion11 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery-ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- HEC Montreal
- Responsible party
- Sponsor
- Investigators
- Florian Robin, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686109
- Sponsor's protocol ID
- 22.220
- Acronym
- BIOBEAT
- Status last verified
- Sep 2023
- First submitted
- 6 Jan 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ancillary Study: Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices: Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05686109
- Acronym / sponsor ID
- BIOBEAT / 22.220
- Keywords
- Monitoring device, Ambulatory surgery, Postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- HEC Montreal
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with no loss of data for a period of 2 consecutive hours over the entire follow-up period.
Time frame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
6 secondary outcomes
Percentage of useful data available per day for the interpretation of vital signs during the first 5 days
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
Patient's experience
Time frame: 7 days after the surgery
Percentage of appropriate and inappropriate clinical decision changes from the clinical intervention decided by the expert committee will be assessed.
Time frame: Up to 60 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Robin, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery-Complications and Patient Satisfaction, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with no loss of data for a period of 2 consecutive hours over the entire follow-up period. (time frame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.