The COSMOS Trial. A Pilot Study A Pilot Study

Surgery Clinical Trial

Official title:

Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280574
• Other study ID #: 21-970
• Status: Recruiting
• Start date: August 10, 2022
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: Roberta Johnson
• Phone: 216-444-9950
• Email: johnsor13[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. Data obtained in the proposed pilot cohort will guide design of a future robust randomized trial comparing clinical interventions and serious complications with blinded versus unblinded continuous ward monitoring.

Description:

The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. The system is a novel battery-powered untethered monitor for continuous monitoring of oxygen saturation, respiratory rate, and pulse rate that is designed for use by patients on surgical wards. The initial phase will evaluate patient tolerance, with clinicians and patients blinded to monitor data. Results will be used to evaluate the frequency of respiratory events and pulse rate abnormalities. These data will be used to design clinical alert settings, based on various durations at various thresholds (e.g., saturation <85% for >1 minute). Our main goal will be to identify clinically meaningful vital sign abnormalities with a minimum of false alerts. Secondarily, the investigators will evaluate the frequency and duration of abnormalities, and the fraction that are detected clinically.

In the second phase of the pilot, clinicians will be unblinded to the GE Portrait monitors, and alerts provided based on the durations and threshold identified in the initial part of the pilot. The primary outcomes will be clinician tolerance and the extent to which clinicians believe that vital sign trending and alerts provided useful information rather than distraction. Specifically, the investigators will assess the fraction of alerts that clinicians deemed meaningful, and the fraction that resulted in clinical interventions. In the third phase of the pilot, the durations and thresholds for saturation, respiratory rate, and pulse rate that trigger alerts will be adjusted based on results from the second phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are admitted to one of the wards equipped with the GE Portrait Mobile Solution.

• Are designated American Society of Anesthesiologists physical status 1-4.

• Had major noncardiac surgery lasting at least 1.5 hours.

• Are expected to remain hospitalized at least two postoperative nights.

• Had general anesthesia with or without neuraxial anesthesia.

Exclusion Criteria:

• Have language, vision, or hearing impairments that may compromise continuous monitoring.

• Are designated Do Not Resuscitate, hospice, or receiving end of life care

• Have previously participated in the study.

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• GE Portrait Monitor
All patients will be monitored
• GE Portrait Monitoring with intervened by clinician
Monitoring might be intervened if clinician believe that the alarm is clinically meaningful
• GE Portrait Monitoring randomized to blinded or unblinded
Without intervention

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total duration of time patients experienced vital sign abnormalities in unblinded vs blinded GE Portrait monitoring	The investigators will determine whether patients with unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution experience less time with vital sign abnormalities as defined in the initial phase of the study. Specifically, the investigators will test the primary hypothesis that the cumulative duration of vital sign abnormalities (using criteria determined in Phase 1) is shorter with unblinded than blinded GE Portrait monitoring in patients recovering from major noncardiac surgery.	Up to 96 hours after surgery
Primary	Vital sign abnormality frequency in unblinded vs blinded GE Portrait monitoring	The investigators will determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution reduces vital sign abnormalities. Specifically, the investigators will test the primary hypothesis that the cumulative duration of vital sign abnormalities (using criteria refined in Phase 2) is shorter with unblinded than blinded GE Portrait monitoring in patients recovering from major noncardiac surgery	Up to 96 hours after surgery