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

856 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators plan to determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.

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 data supports the effectiveness of the treatment GE Portrait Mobile Monitoring Solution for postoperative complications?

Research shows that mobile health systems, like the GE Portrait Mobile Monitoring Solution, can help manage patients after surgery by allowing them to send images and health data to healthcare providers quickly. This can lead to changes in treatment that avoid unnecessary emergency visits, as seen in a study where 18% of cases had their treatment modified based on the data sent, and 96% of patients were satisfied with the mobile health application. ^{1 2 3 4 5}

Is mobile monitoring for postoperative complications safe for humans?

The studies reviewed indicate that using mobile health tools, like smartphone photography and mobile apps, for monitoring postoperative conditions is generally safe and well-received by patients. Patients reported high satisfaction, and the technology helped in accurately detecting complications and reducing unnecessary hospital visits. ^{1 6 7 8 9}

How is the GE Portrait Mobile Monitoring Solution treatment different from other treatments for postoperative complications?

The GE Portrait Mobile Monitoring Solution is unique because it uses mobile technology to continuously monitor patients' vital signs and detect complications in real-time, allowing for early intervention and potentially avoiding unnecessary hospital visits. This approach is different from traditional methods that may rely on less frequent monitoring and in-person check-ups. ^{1 2 10 11 12}

Research Team

Daniel Sessler, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

I am 18 years old or older.

My overall health is good enough for surgery.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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]

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]

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]

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 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]

References

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

Evaluation of a mobile health system for supporting postoperative patients following day surgery. [2017]

2. Canada pubmed.ncbi.nlm.nih.gov

Using a mobile app for monitoring post-operative quality of recovery of patients at home: a feasibility study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Mobile health technology for remote home monitoring after surgery: a meta-analysis. [2021]

4. Canada 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. [2021]

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

Convergent Validity of Three Methods for Measuring Postoperative Complications. [2018]

6. Poland pubmed.ncbi.nlm.nih.gov

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

7. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of safety, effectiveness and reproducibility of telemedicine for neurosurgical screening. [2020]

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

Engaging Patients in Co-Design of Mobile Health Tools for Surgical Site Infection Surveillance: Implications for Research and Implementation. [2020]

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

Identification of Important Features in Mobile Health Applications for Surgical Site Infection Surveillance. [2020]

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

Postoperative real-time electrocardiography monitoring detects myocardial ischemia: a case report. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Use of mobile health technologies for postoperative care in paediatric surgery: A systematic review. [2022]

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

Mobile phone-based telemedicine system for the home follow-up of patients undergoing ambulatory surgery. [2022]