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

Trial Summary

What is the purpose of this trial?

To assess the feasibility of evaluating postoperative home monitoring with Biobeat digital monitoring. The investigators hypothesize that the Biobeat digital home monitoring platform will lead to a decrease in unplanned visits to the ED (Emergency Department). In addition, patients' quality of life is postulated to be improved compared to patients receiving the current standard of care without home monitoring.

Is Biobeat Digital Home Monitoring safe for humans?

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 studies suggest it can safely detect changes in vital signs, potentially more quickly than traditional methods, but specific safety data for humans is not detailed in the available research. ¹

How is Biobeat Digital Home Monitoring different from other treatments for post-thoracic surgery care?

Biobeat Digital Home Monitoring is unique because it uses wearable technology to remotely monitor patients' health after thoracic surgery, providing real-time data and potentially improving recovery by allowing for early detection of complications, unlike traditional methods that rely on in-person visits. ^{2 3 4 5 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Screening for postoperative complications by continuous monitoring: protocol for the Biobeat-Postop cohort study. [2022]

2. England 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. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Wearable Cardiac Rhythm Monitoring Device for Detection of Postoperative Atrial Fibrillation. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Smart bracelet to assess physical activity after cardiac surgery: A prospective study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Using accelerometers to characterize recovery after surgery in children. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Design and implementation of a digital health home spirometry intervention for remote monitoring of lung transplant function. [2023]