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Completed

NCT Number: NCT05280574

The COSMOS Trial. A Pilot Study A Pilot Study

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.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blinded GE Portrait Monitoring

Device

Continuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians.

Unblinded GE Portrait Monitoring

Device

Continuous vital signs will be monitored and evaluated by clinicians using GE Portrait.

Primary outcomes

  1. Phase 2- Cumulative Duration of Vital Sign Abnormalities

    Time frame: Up to 72 hours after surgery

    The vital sign abnormalities is a 5-component composite including the durations of SpO2 <85%, heart rate <45/min, heart rate >130/min, respiratory rate <4/min and respiratory rate >30/min.

Secondary outcomes

  1. Phase 2 - Alerts Deemed Meaningful

    Time frame: During postoperative 72 hours

    Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group

  2. Phase 2 - Clinical Interventions to Meaningful Alarms

    Time frame: During postoperative 72 hours

    Number of clinical interventions by the three categories of meaningful alarms (informative, important, and critical).

    An investigator will ask the relevant clinician (usually a nurse) to rate each alert as clinically meaningful or not. Specifically, clinicians will be asked to rate alerts as "critical," "important," "informative," or "false or distracting." The terms will intentionally not be further defined, thereby allowing caregivers to determine themselves the extent to which a given alert was helpful or not. Caregivers will be queried in person shortly after each alert, typically within 15 minutes. The thresholds, determined in the initial phase, will be set to generate an average of about 2 alerts per patient per day - and therefore will not be onerous for clinicians.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2022
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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