The COSMOS Trial. A Pilot Study A Pilot Study

NeuroTherapia, Inc.

Status: Completed

Conditions: Surgery

Treatments: Device: Unblinded GE Portrait Monitoring; Device: Blinded GE Portrait Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT05280574

21-970

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 3 patient groups

Phase 1 - prospective observational cohort study: Blinded GE Portrait monitoring

Description:

Patients in phase 1 will receive continuous vital sign monitoring blinded to patients and clinicians.

Treatment:

Device: Blinded GE Portrait Monitoring

Phase 2- randomized trial: Blinded GE Portrait monitoring

Description:

Continuous vital signs will be monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead will rely on routine vital sign assessments at 4-hour intervals.

Treatment:

Device: Blinded GE Portrait Monitoring

Phase 2- randomized trial: Unblinded GE Portrait monitoring

Description:

Physician investigators will monitor and evaluate continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring. Patients who are randomized to the unblinded GE Portrait monitoring might be intervened if the clinicians believe that the alarm is clinically meaningful.

Treatment:

Device: Unblinded GE Portrait Monitoring