Biobeat Digital Home Monitoring for Post-Thoracic Surgery Care

Overseen By Deb Lewis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Discomfort with technology

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Biobeat digital home monitoring aids recovery after lung cancer surgery. The study evaluates whether home monitoring reduces unexpected emergency room visits and improves quality of life compared to usual care. Participants will either use digital devices at home to monitor their health or receive standard care without these devices. The trial seeks patients who are comfortable with technology, have undergone lung cancer surgery, and have internet access at home. As an unphased trial, this study provides patients an opportunity to contribute to innovative research that could enhance post-surgery recovery for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Biobeat Digital Home Monitoring is safe for post-thoracic surgery care?

Research has shown that Biobeat Digital Home Monitoring can safely track vital signs like heart rate and blood pressure, potentially faster than traditional methods. While detailed safety information for humans remains limited, other studies have used the technology without major safety issues, suggesting it is generally safe. As this trial is not in its early stages, there is reasonable confidence in its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Biobeat Digital Home Monitoring because it brings a fresh approach to post-thoracic surgery care by allowing patients to be monitored from home. Unlike traditional follow-up visits and check-ins with healthcare providers, this system uses non-invasive devices to track vital signs like blood pressure and oxygen levels right from the comfort of the patient's home. This method not only aims to improve patient comfort and convenience but also enhances communication between patients and healthcare providers through digital channels, potentially leading to more timely interventions and better overall outcomes.

What evidence suggests that Biobeat Digital Home Monitoring is effective for post-thoracic surgery care?

Research has shown that the Biobeat digital home monitoring system effectively tracks key health indicators like heart rate, blood pressure, and oxygen levels in post-surgery patients. In this trial, participants in the Digital Group will use the Biobeat system to monitor these vital signs at home. Studies suggest that this digital system might enhance post-surgery care compared to traditional methods. The Biobeat system has been used in various healthcare settings to continuously and easily monitor patients' vital signs. In previous cases, this method demonstrated potential in reducing complications and unexpected hospital visits after surgery. These findings suggest that Biobeat could improve recovery and quality of life for patients after thoracic surgery. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients who are about to have elective lung cancer surgery, are willing to consent, have Wi-Fi or cellular connectivity at home, and are comfortable using technology like online banking. It's not for those uncomfortable with tech use.

Inclusion Criteria

Patient willing to provide informed consent

Wi-fi or cellular connectivity at the patient's home

Patient familiar/comfortable with the use of technology such as online banking

Exclusion Criteria

I am not comfortable using technology.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative Monitoring

Participants receive Biobeat digital home monitoring and two-way communication for 4 weeks post-operatively

4 weeks

Daily monitoring (twice a day)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biobeat Digital Home Monitoring

Trial Overview

The study is testing the Biobeat digital home monitoring system to see if it can reduce unplanned emergency visits and improve quality of life after thoracic surgery compared to standard care without home monitoring.

How Is the Trial Designed?

Group I: Digital Group Experimental Treatment 1 Intervention

At the time of hospital discharge, the control group will be discharged without receipt of home monitoring, and the intervention group will receive a home monitoring kit with (NIBP (non-invasive blood pressure) and SPO2 (pulse oximetry) with instructions on how to use these devices. Patients in the intervention groups will receive digital communication for four weeks and have their NIBP, HR (heart rate), SPO2 and pain scores evaluated twice a day for two weeks.

Group II: Control Group Active Control 1 Intervention

The control group will not be monitored with continuity of care.

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Published Research Related to This Trial

A study involving 100 patients after cardiac surgery showed that using a connected bracelet to monitor physical activity is effective and well-tolerated, with 94% compliance to the device.

Patients increased their daily steps from an average of 1454 steps at discharge to about 5801 steps by Day 60, achieving 85% of their activity level within the first month post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart bracelet to assess physical activity after cardiac surgery: A prospective study. Hauguel-Moreau, M., Naudin, C., N'Guyen, L., et al.[2021]

An automated, chat-based digital health intervention for lung transplant patients effectively monitored lung function using home spirometry, with 371 out of 544 invited patients actively participating and submitting data.

The program demonstrated high patient engagement, with a strong correlation between home and laboratory FEV1 values, and provided timely alerts for declines in lung function, indicating its potential for early detection of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a digital health home spirometry intervention for remote monitoring of lung transplant function. Odisho, AY., Liu, AW., Maiorano, AR., et al.[2023]

The study found that postoperative atrial fibrillation (POAF) occurred in 21.2% of patients who underwent combined CABG and valve surgery, indicating a higher risk for these patients compared to those who had isolated CABG (8.2%) or isolated valve surgery (13.5%).

The wearable, patch-based cardiac rhythm monitoring device proved to be an effective tool for detecting POAF, especially in patients who underwent valve surgery, highlighting its potential for improving patient outcomes after cardiac surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Cardiac Rhythm Monitoring Device for Detection of Postoperative Atrial Fibrillation. Hibino, M., Pandey, AK., Verma, S., et al.[2023]

This study will monitor 114 adult patients after non-cardiac surgery using a wearable sensor for 72 hours to detect hemodynamic, respiratory, and temperature abnormalities, aiming to improve postoperative care.

The researchers hypothesize that remote monitoring with the wearable device will identify vital sign abnormalities more effectively and quickly than traditional nurse follow-ups, potentially leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for postoperative complications by continuous monitoring: protocol for the Biobeat-Postop cohort study. Paternot, A., Aegerter, P., Martin, A., et al.[2022]

A systematic review of five studies on wearable activity monitors and smartphone apps for rehabilitation after total hip replacement (THR) found limited evidence supporting their long-term efficacy in enhancing recovery and patient monitoring.

The review highlights the need for further research to identify which specific technologies are most beneficial for patients and how they can effectively improve clinical outcomes after THR surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of current use of commercial wearable technology and smartphone apps with application in monitoring individuals following total hip replacement surgery. Bahadori, S., Collard, S., Williams, JM., et al.[2021]

The use of accelerometers to monitor physical activity in children after surgery is feasible, with 25 out of 60 enrolled patients successfully completing the study, providing objective data on recovery.

Recovery trajectories differ between inpatient and outpatient procedures, with outpatient patients returning to preoperative light physical activity levels by day 7 and moderate-to-vigorous activity peaking at 90% by day 8, while inpatient patients showed slower recovery rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using accelerometers to characterize recovery after surgery in children. Ghomrawi, HM., Baumann, LM., Kwon, S., et al.[2018]

Citations

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withpower.com/trial/phase-home-monitoring-5-2024-2212d

Biobeat Digital Home Monitoring for Post-Thoracic Surgery ...

The Biobeat wearable sensor has been used in studies to monitor vital signs like heart rate, respiratory rate, and temperature in patients after surgery. These ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11888079/

Enhancing Quadruple Health Outcomes After Thoracic Surgery

Digital home monitoring (DHM) may improve postoperative care compared to standard methods. Objective. We conducted a feasibility study for a ...

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periop.jmir.org

periop.jmir.org/2025/1/e58998

Enhancing Quadruple Health Outcomes After Thoracic Surgery

Digital home monitoring (DHM) may improve postoperative care compared to standard methods. Objective: We conducted a feasibility study for a ...

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journals.sagepub.com

journals.sagepub.com/doi/10.1177/20552076251324012?icid=int.sj-abstract.similar-articles.4

Biobeat monitor utilization in various healthcare settings

A pilot study of blood pressure monitoring after cardiac surgery using a wearable, non-invasive sensor. Front Med (Lausanne) 2021; 8: 693926 ...

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researchgate.net

researchgate.net/publication/389357660_Continuous_vital_sign_monitoring_with_Biobeat_wearable_devices_for_post-ambulatory_surgery_patients_a_pilot_feasibility_study

Continuous vital sign monitoring with Biobeat wearable ...

A Pilot Study of Blood Pressure Monitoring After Cardiac Surgery Using a Wearable, Non-invasive Sensor. Article. Full-text available. Aug 2021.

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clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT06417996?draw=2&rank=1

NCT06417996 | Biobeat Digital Home Monitoring Feasibility

A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8546735/

protocol for the Biobeat-Postop cohort study

The main outcome of the study which is the occurrence of one or more episodes with a mean arterial pressure below the threshold of 60 mmHg during the first 72 ...