N/A
Completed N=250
The COSMOS Trial. A Pilot Study A Pilot Study
Surgery
Source: ClinicalTrials.gov NCT05280574 ↗
Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Phase 2- Cumulative Duration of Vital Sign Abnormalities — 6.2; 4.2; 0; 0 minutes beyond threshold — p=< 0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 2- Cumulative Duration of Vital Sign Abnormalities |
6.2; 4.2; 0; 0; 8.4; 10 | < 0.05 sig |
| SECONDARY Phase 2 - Alerts Deemed Meaningful |
60 | — |
| SECONDARY Phase 2 - Clinical Interventions to Meaningful Alarms |
10; 21; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05280574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.