SurgeryNCT05280574
The COSMOS Trial. A Pilot Study A Pilot Study
An observational study of Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Blinded GE Portrait Monitoring and Unblinded GE Portrait Monitoring
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2022to 30 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial 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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Blinded GE Portrait Monitoring, Unblinded GE Portrait Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded GE Portrait MonitoringDevice
Continuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians.
Unblinded GE Portrait MonitoringDevice
Continuous vital signs will be monitored and evaluated by clinicians using GE Portrait.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Blinded GE Portrait Monitoring | |
| 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. Receives: Device: Blinded GE Portrait Monitoring | |
| 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. Receives: Device: Unblinded GE Portrait Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 hours after surgery
Secondary outcomes (2)
Phase 2 - Alerts Deemed Meaningful
Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group
Measured: During postoperative 72 hours
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.
Measured: During postoperative 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start10 Aug 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280574
- Sponsor's protocol ID
- 21-970
- Status last verified
- Jan 2025
- First submitted
- 22 Feb 2022
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41168018Anusic 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.
PubMed 39531997
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial A Pilot Study
- ClinicalTrials.gov ID
- NCT05280574
- Acronym / sponsor ID
- 21-970
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - prospective observational cohort study: Blinded GE Portrait monitoring | – | Device: Blinded GE Portrait MonitoringPatients in phase 1 will receive continuous vital sign monitoring blinded to patients and clinicians. |
| Phase 2- randomized trial: Blinded GE Portrait monitoring | – | Device: Blinded GE Portrait MonitoringContinuous 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. |
| Phase 2- randomized trial: Unblinded GE Portrait monitoring | – | Device: Unblinded GE Portrait MonitoringPhysician 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blinded GE Portrait MonitoringContinuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians. | Device | Phase 1 - prospective observational cohort study: Blinded GE Portrait monitoring, Phase 2- randomized trial: Blinded GE Portrait monitoring |
| Unblinded GE Portrait MonitoringContinuous vital signs will be monitored and evaluated by clinicians using GE Portrait. | Device | Phase 2- randomized trial: Unblinded GE Portrait monitoring |
Primary outcome
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.
2 secondary outcomes
Phase 2 - Alerts Deemed Meaningful
Time frame: During postoperative 72 hours
Phase 2 - Clinical Interventions to Meaningful Alarms
Time frame: During postoperative 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41168018Anusic 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.
- Derived from this study: PubMed 39531997Anusic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Sessler, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2- Cumulative Duration of Vital Sign Abnormalities (time frame: Up to 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280574, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.