Mobile Monitoring for Postoperative Complications

(COSMOS Trial)

Overseen By Lisa Humbert, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Language, vision, hearing impairments, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for monitoring patients after major non-cardiac surgeries. It uses the GE Portrait Mobile Monitoring Solution, a mobile system, to track vital signs and determine if it can detect problems earlier. The trial includes two groups: one where the medical team accesses the monitoring data and another where they do not. It seeks participants planning to undergo major surgery lasting over 1.5 hours with an overnight hospital stay. Participants should not have conditions that complicate monitoring, such as significant hearing or vision problems.

As a Phase 2 trial, this research measures the effectiveness of the monitoring solution in an initial, smaller group, allowing participants to contribute to innovative healthcare solutions.

Will I have to stop taking my current medications?

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 GE Portrait Mobile Monitoring Solution is safe for postoperative patients?

Research has shown that the GE Portrait Mobile Monitoring Solution is safe and easy for patients to use. A previous study found that this system effectively tracks changes in vital signs without causing harm. It provides real-time alerts about a patient's condition, reducing the risk of complications after surgery.

The device is wireless and wearable, offering convenience for patients. Studies have not reported any negative effects directly linked to this monitoring solution, suggesting it is safe for patients recovering from surgery. The device aims to improve patient outcomes by closely monitoring vital signs like breathing rate and oxygen levels, enabling healthcare providers to respond quickly if any issues arise.

Overall, the available safety data supports using the GE Portrait Mobile Monitoring Solution as a reliable tool for post-surgery care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of continuous postoperative vital sign monitoring using the GE Portrait Mobile Monitoring Solution. Unlike traditional intermittent monitoring, this mobile solution offers constant, real-time data, which may help in early detection of complications after surgery. The trial includes two unique approaches: blinded monitoring, where data is hidden from clinicians, and unblinded monitoring, where data is visible to healthcare providers. Understanding the impact of continuous monitoring could lead to significant improvements in patient outcomes by allowing for quicker interventions and more personalized care.

What evidence suggests that the GE Portrait Mobile Monitoring Solution is effective for reducing vital sign abnormalities in postoperative patients?

Research has shown that the GE Portrait Mobile Monitoring Solution helps reduce unusual vital signs in patients recovering from major surgeries. In this trial, participants will be assigned to either a blinded or unblinded monitoring arm using this device. A small study found that continuous monitoring with this device lowered these abnormalities by 25%. Additionally, 82% of the alarms from the device proved helpful, prompting quick responses from healthcare staff. This indicates that the device can improve patient care by alerting nurses to important changes in a patient's condition. Overall, the evidence supports that this monitoring solution enhances care after surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Ryu Komatsu, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are recovering from major noncardiac surgery that lasted at least 1.5 hours, will stay in the hospital overnight, and had general or neuraxial anesthesia. They should be in a physical condition rated between 1-4 by the American Society of Anesthesiologists.

Inclusion Criteria

Expected to be admitted to one of the wards equipped with the GE Portrait Mobile Monitoring Solution

My overall health is good enough for surgery.

I am scheduled for a major surgery that will last at least 1.5 hours.

Exclusion Criteria

Expected to have telemetry monitoring

Have previously participated in the study

I am under end-of-life care plans like Do Not Resuscitate or hospice.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts to reduce vital sign abnormalities during the initial 48 postoperative hours

48 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GE Portrait Mobile Monitoring Solution

Trial Overview

The COSMOS Trial is testing if continuous monitoring with GE Portrait Mobile Monitoring Solution and nurse alerts can reduce post-surgery vital sign abnormalities compared to standard care without constant monitoring.

How Is the Trial Designed?

Group I: Unblinded monitoring Experimental Treatment 1 Intervention

Continuous postoperative vital sign monitoring unblinded to clinicians and investigators.

Group II: Blinded monitoring Experimental Treatment 1 Intervention

Continuous postoperative vital sign monitoring blinded to clinicians and investigators.

GE Portrait Mobile Monitoring Solution is already approved in European Union, United States for the following indications:

Approved in European Union as Portrait Mobile for:

• Post-surgical monitoring
• Critical care monitoring

Approved in United States as Portrait Mobile for:

• Post-surgical monitoring
• Critical care monitoring

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

A scoping review of 34 studies on patient-generated health data (PGHD) for monitoring surgical site infections (SSI) revealed that while patient satisfaction was commonly measured, only a few studies involved patients in developing PGHD tools.

Interviews with 24 stakeholders highlighted the critical need for patient involvement in designing mHealth interventions, emphasizing that incorporating patient perspectives can enhance the effectiveness and acceptance of these technologies in post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Patients in Co-Design of Mobile Health Tools for Surgical Site Infection Surveillance: Implications for Research and Implementation. Lavallee, DC., Lee, JR., Semple, JL., et al.[2020]

A study involving 27 postoperative patients demonstrated that monitoring wound healing through smartphone-captured photographs sent via WhatsApp is feasible and effective, with 100% accuracy in detecting complications.

The method was well-received, with 81% of patients expressing satisfaction, suggesting that remote photographic assessments could reduce the need for in-person follow-ups and ease the burden on healthcare facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone photography for smart assessment of post-surgical wounds - an experience during the COVID-19 pandemic. Salati, SA.[2022]

A study involving 65 patients showed that using a mobile app for post-operative monitoring was feasible, with high patient engagement as evidenced by an average of 23.9 logins for breast surgery patients and 19.3 for orthopedic patients over 30 days.

Both patients and surgeons reported high satisfaction with the mobile app, scoring it around 3.9 and 3.7 out of 4, indicating that the app effectively facilitated monitoring and could improve post-operative care efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a mobile app for monitoring post-operative quality of recovery of patients at home: a feasibility study. Semple, JL., Sharpe, S., Murnaghan, ML., et al.[2022]

A pilot study involving 96 patients demonstrated that a mobile phone-based telemedicine system effectively improved follow-up care after ambulatory surgery by allowing patients to send images of their surgical wounds for assessment.

The system significantly reduced unnecessary hospital visits, with only 1 out of 96 patients needing to return to the hospital, while 66.7% of patients' concerns were resolved through image evaluation, leading to increased patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone-based telemedicine system for the home follow-up of patients undergoing ambulatory surgery. Martínez-Ramos, C., Cerdán, MT., López, RS.[2022]

Out of 10 evaluated mHealth applications for surgical site infection (SSI) detection, only two are currently in full clinical use, highlighting a gap in practical implementation despite the availability of technology.

The apps collected various data types, such as wound photographs and medication adherence, but their integration with electronic health records varied, indicating a need for standardized evaluation methods in mHealth technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Important Features in Mobile Health Applications for Surgical Site Infection Surveillance. Chernetsky Tejedor, S., Sharma, J., Lavallee, DC., et al.[2020]

A mobile phone system for postoperative management allowed 49 patients to send images and pulse oximetry readings to healthcare providers, resulting in quicker assessments and modifications to treatment in 18% of cases, which helped avoid unnecessary emergency visits.

Patient satisfaction was very high, with 96% of users reporting complete satisfaction with the care received through the mobile health application, indicating its effectiveness and acceptability for managing postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile health system for supporting postoperative patients following day surgery. Pérez, F., Montón, E., Nodal, MJ., et al.[2017]

Remote continuous ECG monitoring via smartphone was successfully used in a 42-year-old male patient after prostate surgery, allowing for real-time detection of myocardial ischemia, which was confirmed by a 12-lead ECG.

The timely intervention, including administration of metoprolol and a blood transfusion, effectively normalized the patient's ST segments, demonstrating that this technology can potentially prevent postoperative myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative real-time electrocardiography monitoring detects myocardial ischemia: a case report. Yang, H., Fayad, A., Chaput, A., et al.[2017]

The systematic review of 18 studies indicates that mHealth systems, such as mobile apps and texting, can significantly improve postoperative care for children by increasing follow-up appointment attendance and reducing complications and emergency department visits.

Despite the positive outcomes associated with mHealth, many studies had methodological issues, highlighting the need for more rigorous research to establish the effectiveness and best practices for implementing these technologies in pediatric postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of mobile health technologies for postoperative care in paediatric surgery: A systematic review. Nguyen, N., Leveille, E., Guadagno, E., et al.[2022]

A study analyzing 232 emergency neurosurgical cases found that using smartphones for patient screening achieved a high accuracy of 95.69% in identifying changes in CT scans, indicating its effectiveness in assessing serious conditions.

The telemedicine approach demonstrated safety and reproducibility, with 100% concordance in cases requiring surgical treatment, suggesting it can improve patient outcomes by reducing unnecessary transfers and speeding up specialist consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of safety, effectiveness and reproducibility of telemedicine for neurosurgical screening. Esteves, LA., Ribeiro, AT., Silva, EGD., et al.[2020]

The Swedish Web Version of the Quality of Recovery Scale (SwQoR-LA) has been shown to be a valid and reliable tool for assessing postoperative recovery in 107 patients, demonstrating good internal consistency and responsiveness.

Using the SwQoR-LA via a mobile app allows for real-time monitoring of recovery, helping to identify patients who may need timely interventions, thus improving postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swedish Web Version of the Quality of Recovery Scale Adapted for Patients Undergoing Local Anesthesia and Peripheral Nerve Blockade (SwQoR-LA): Prospective Psychometric Evaluation Study. Nilsson, U., Dahlberg, K., Jaensson, M.[2021]

In a study of 1,578 adult surgical patients, patient-reported outcomes on postoperative complications showed poor-to-moderate agreement with automated and manual chart reviews, indicating that patients may not accurately identify in-hospital complications.

While patient reports can capture subjective experiences after discharge, discrepancies often arise from patients referencing events outside the intended time frame, suggesting the need for better communication and survey design to improve data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Convergent Validity of Three Methods for Measuring Postoperative Complications. Fritz, BA., Escallier, KE., Ben Abdallah, A., et al.[2018]

A systematic review of 45 studies found that using mobile health (mHealth) technology for post-surgery monitoring is associated with significantly fewer emergency department visits (odds ratio 0.42) and readmissions (odds ratio 0.47), indicating improved postoperative recovery.

Patients using mHealth reported accelerated improvements in quality of life after surgery, suggesting that remote monitoring can enhance the effectiveness of postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health technology for remote home monitoring after surgery: a meta-analysis. Dawes, AJ., Lin, AY., Varghese, C., et al.[2021]

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