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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 - prospective observational cohort study: Blinded GE Portrait monitoring | Patients in phase 1 will receive continuous vital sign monitoring blinded to patients and clinicians. |
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| Phase 2- randomized trial: Blinded GE Portrait monitoring | 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. |
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| Phase 2- randomized trial: Unblinded GE Portrait monitoring | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinded GE Portrait Monitoring | Device | Continuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 2- Cumulative Duration of Vital Sign Abnormalities | 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. | Up to 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2 - Alerts Deemed Meaningful | Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group | During postoperative 72 hours |
| Phase 2 - Clinical Interventions to Meaningful Alarms |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Sessler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41168018 | Derived | Anusic N, Gulluoglu A, Ekrami E, Mascha EJ, Li S, Coffeng R, Turan A, Clemens A, Perez C, Beard JW, Sessler DI; COSMOS Pilot Investigators. Corrigendum to 'Continuous Vital Sign Monitoring on Surgical Wards: The COSMOS Pilot. J Clin Anesth. 2026 Jan;108:111878. doi: 10.1016/j.jclinane.2025.111878. Epub 2025 Oct 30. | |
| 39531997 | Derived |
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Phase 1: A prospective observation cohort phase (no randomization) designed to identify suitable alert thresholds for continuous oxygen saturation, heart rate, and respiratory rate for phase 2. Patient characteristics weren't collected per protocol, ,and analysis was completely qualitative.
Phase 2: A randomized trial phase. 176 patients consented, 26 patients withdrew before randomization:
Phase 1 enrolled 100 patients with continuous vital sign monitoring blinded to patients and clinicians.
Phase 2 randomized 150 patients to either blinded or unblinded continuous monitoring.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 - Prospective Observational Cohort Study: Blinded GE Portrait Monitoring | Patients received continuous vital sign monitoring blinded to patients and clinicians. Phase 1 was a prospective cohort study without randomization. Patient characteristics weren't collected per protocol, and analysis was completely qualitative. |
| FG001 | Phase 2 - Randomized Trial: Unblinded GE Portrait Monitoring | Physician investigators monitored and evaluated continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring. |
| FG002 | Phase 2 - Randomized Trial: Blinded GE Portrait Monitoring | Continuous vital signs were monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead relied on routine vital sign assessments at 4-hour intervals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 2- Randomized Trial: Blinded GE Portrait Monitoring | Continuous vital signs were monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead relied on routine vital sign assessments at 4-hour intervals. |
| BG001 | Phase 2- Randomized Trial: Unblinded GE Portrait Monitoring |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 2- Cumulative Duration of Vital Sign Abnormalities | 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. | Monitor data for one patient in the blinded group was lost so we assumed that AET for all five outcomes were zero. | Posted | Median | Inter-Quartile Range | minutes beyond threshold | Up to 72 hours after surgery |
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During the first 72 postoperative hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 - Prospective Observational Cohort Study: Blinded GE Portrait Monitoring | Patients received continuous vital sign monitoring blinded to patients and clinicians. Phase 1 was a prospective cohort study and no randomization was done |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel I. Sessler MD, Professor and Michael Cudahy Chair | Outcomes Research Consortium, Department of Anesthesiology, Cleveland Clinic, Cleveland, Ohio | 216-870-2620 | DS@OR.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2022 | Sep 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2022 | Sep 16, 2024 | ICF_001.pdf |
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| Unblinded GE Portrait Monitoring | Device | Continuous vital signs will be monitored and evaluated by clinicians using GE Portrait. |
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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.
| During postoperative 72 hours |
| Anusic N, Gulluoglu A, Ekrami E, Mascha EJ, Li S, Coffeng R, Turan A, Clemens A, Perez C, Beard JW, Sessler DI; COSMOS Pilot Investigators. Continuous vital sign monitoring on surgical wards: The COSMOS pilot. J Clin Anesth. 2024 Dec;99:111661. doi: 10.1016/j.jclinane.2024.111661. Epub 2024 Nov 11. |
Physician investigators monitored and evaluated 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Missing data points: 1 for unblinded group and 2 for blinded group | Count of Participants | Participants |
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| Body Mass Index | Missing data point: 1 for blinded group. | Mean | Standard Deviation | kg/m^2 |
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| American Society of Anesthesiologists (ASA) physical status | Count of Participants | Participants |
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| Smoking status | Missing data point: 5 for blinded group and 3 for unblinded group | Count of Participants | Participants |
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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. |
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| Secondary | Phase 2 - Alerts Deemed Meaningful | Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group | We analyzed 73 patients in the unblinded GE Portrait monitoring group, with a total of 73 alarms recorded. Among them, 41 patients experienced no alarms, while the remaining 32 patients accounted for all 73 alarms. | Posted | Number | Meaningful alarms | During postoperative 72 hours | Alarms | Alarms |
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| Secondary | Phase 2 - Clinical Interventions to Meaningful Alarms | 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. | We analyzed 73 patients in the unblinded GE Portrait monitoring group, with a total of 73 alarms recorded. Among them, 41 patients experienced no alarms, while the remaining 32 patients accounted for all 73 alarms. Out of the 73 alarms, 60 alarms were categorized as informative, important, or critical by the responsible nurse. | Posted | Count of Units | Meaningful alarms | During postoperative 72 hours | Meaningful alarms | Meaningful alarms |
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| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Phase 2- Randomized Trial: Unblinded GE Portrait Monitoring | Physician investigators monitored and evaluated continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring. | 0 | 73 | 0 | 73 | 0 | 73 |
| EG002 | Phase 2- Randomized Trial: Blinded GE Portrait Monitoring | Continuous vital signs were monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead relied on routine vital sign assessments at 4-hour intervals. | 0 | 75 | 0 | 75 | 0 | 75 |
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| Other |
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| Moderate |
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| Severe |
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| Former (> 6 weeks) |
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| Important alarm |
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| Critical alarm |
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