Clinical trial NCT05280574: The COSMOS Trial. A Pilot Study A Pilot Study
Official title: Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are older than 18 years of age. Patients have a ASA status 1-4. The patients whom had a major noncardiac surgery lasting at least 1.5 hours and are expected to remain hospitalized at least two postoperative nights, and are being admitted to a ward equipped with the GE Portrait Mobile Monitor.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phase 2- Cumulative Duration of Vital Sign Abnormalities
timeFrame: Up to 72 hours after surgery
Secondary outcomes:
measure: Phase 2 - Alerts Deemed Meaningful
timeFrame: During postoperative 72 hours
measure: Phase 2 - Clinical Interventions to Meaningful Alarms
timeFrame: During postoperative 72 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel Sessler, MD
role: PRINCIPAL_INVESTIGATOR
References: