Postoperative ComplicationsCOSMOSNCT06133140
Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial
An observational study of Postoperative Complications, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators plan to determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Unblinded postoperative vital sign monitoring and Blinded postoperative vital sign monitoring
- Type of treatment
- Medical device
- How many people
- 227 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 6 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 expected to be admitted to one of the wards equipped with the GE Portrait Mobile Monitoring Solution;
- Are ≥18 years old;
- Are designated American Society of Anesthesiologists physical status 1-4;
- Are scheduled for major noncardiac surgery lasting at least 1.5 hours;
- Are expected to remain hospitalized at least one postoperative night;
- Are expected to have general or neuraxial anesthesia.
Who cannot join
- Have language, vision, or hearing impairments that might compromise continuous monitoring;
- Are designated Do Not Resuscitate, hospice, or receiving end of life care;
- Are expected to have telemetry monitoring;
- Have previously participated in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators plan to determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.
Read the detailed description
Primary Aim. Determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.
Primary hypothesis. Unblinded continuous ward monitoring and nurse alerts reduces vital sign abnormalities during the initial 48 postoperative hours after major non-cardiac surgery while patients remain hospitalized.
Secondary Aim. Determine whether continuous ward saturation, ventilation, and pulse rate monitoring reduces a composite of substantive respiratory and cardiovascular interventions.
Secondary hypothesis. Unblinded continuous ward monitoring increases a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, and bradycardia within 48 hours after major non-cardiac surgery.
- Conditions
- Postoperative Complications
- Being tested
- Unblinded postoperative vital sign monitoring, Blinded postoperative vital sign monitoring
- Keywords
- Postoperative, Anesthesia, Vital signs
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unblinded postoperative vital sign monitoringDevice
Also called Unblinded group
Unblinded postoperative GE Portrait monitoring
Blinded postoperative vital sign monitoringDevice
Also called Blinded group
Blinded postoperative GE Portrait monitoring
| Study group | Role | What they receive |
|---|---|---|
| Blinded monitoring | Continuous postoperative vital sign monitoring blinded to clinicians and investigators. Receives: Device: Blinded postoperative vital sign monitoring | |
| Unblinded monitoring | Continuous postoperative vital sign monitoring unblinded to clinicians and investigators. Receives: Device: Unblinded postoperative vital sign monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Area of oxygen saturation defined as SpO2 ≤85%.
Measured: 48 postoperative hours.
Inadequate or excessive ventilation
Area of inadequate or excessive ventilation defined as respiratory rate ≤4/min or ≥30/min.
Measured: 48 postoperative hours.
Bradycardia and tachycardia
Area of inadequate or excessive heart rate defined as ≤40/min or ≥130/min.
Measured: 48 postoperative hours.
Secondary outcomes (1)
The fraction of patients who have a composite of interventions potentially related to postoperative vital sign abnormalities.
Determine whether continuous ward saturation, ventilation, and pulse rate monitoring reduces substantive respiratory and cardiovascular interventions. Each intervention will be considered dichotomously (occurred or not), and together constitute a composite outcome:
- Supplemental oxygen (or substantive dose escalation as indicated by a new administration method) excluding oxygen that patients are already using when they arrive on the ward;
- New-onset inhaled drugs (e.g., steroids, bronchodilators);
- Naloxone or flumazenil administration;
- Non-invasive ventilatory support including bag \& mask ventilation, but excluding use of home CPAP and similar devices;
- Bolus fluid administration (e.g., >500 ml);
- Drug treatments for bradycardia (e.g., new onset atropine or glycopyrrolate) and discontinuing drugs that promote bradycardia such as beta blockers;
- Drug treatment for tachycardia (e.g., new onset beta blockers and calcium channel blockers).
Measured: 48 postoperative hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start14 Feb 2024
- Primary completion1 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Other
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryu Komatsu, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133140
- Sponsor's protocol ID
- 24-009
- Acronym
- COSMOS
- Status last verified
- Jan 2026
- First submitted
- 1 Nov 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared collaboratively upon approval of the Steering Committee and appropriate data-use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. 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
- ClinicalTrials.gov ID
- NCT06133140
- Acronym / sponsor ID
- COSMOS / 24-009
- Conditions
- Postoperative Complications
- Keywords
- Postoperative, Anesthesia, Vital signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
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 to determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.
Detailed description
Primary Aim. Determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.
Primary hypothesis. Unblinded continuous ward monitoring and nurse alerts reduces vital sign abnormalities during the initial 48 postoperative hours after major non-cardiac surgery while patients remain hospitalized.
Secondary Aim. Determine whether continuous ward saturation, ventilation, and pulse rate monitoring reduces a composite of substantive respiratory and cardiovascular interventions.
Secondary hypothesis. Unblinded continuous ward monitoring increases a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, and bradycardia within 48 hours after major non-cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded monitoring | – | Device: Blinded postoperative vital sign monitoringContinuous postoperative vital sign monitoring blinded to clinicians and investigators. |
| Unblinded monitoring | – | Device: Unblinded postoperative vital sign monitoringContinuous postoperative vital sign monitoring unblinded to clinicians and investigators. |
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 (6 listed)
- Are expected to be admitted to one of the wards equipped with the GE Portrait Mobile Monitoring Solution;
- Are ≥18 years old;
- Are designated American Society of Anesthesiologists physical status 1-4;
- Are scheduled for major noncardiac surgery lasting at least 1.5 hours;
- Are expected to remain hospitalized at least one postoperative night;
Key exclusion criteria (4 listed)
- Have language, vision, or hearing impairments that might compromise continuous monitoring;
- Are designated Do Not Resuscitate, hospice, or receiving end of life care;
- Are expected to have telemetry monitoring;
- 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 |
|---|---|---|
| Unblinded postoperative vital sign monitoringAlso: Unblinded groupUnblinded postoperative GE Portrait monitoring | Device | Unblinded monitoring |
| Blinded postoperative vital sign monitoringAlso: Blinded groupBlinded postoperative GE Portrait monitoring | Device | Blinded monitoring |
Primary outcome
Hypoxemia
Time frame: 48 postoperative hours.
Area of oxygen saturation defined as SpO2 ≤85%.
Inadequate or excessive ventilation
Time frame: 48 postoperative hours.
Area of inadequate or excessive ventilation defined as respiratory rate ≤4/min or ≥30/min.
Bradycardia and tachycardia
Time frame: 48 postoperative hours.
Area of inadequate or excessive heart rate defined as ≤40/min or ≥130/min.
1 secondary outcome
The fraction of patients who have a composite of interventions potentially related to postoperative vital sign abnormalities.
Time frame: 48 postoperative hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be shared collaboratively upon approval of the Steering Committee and appropriate data-use agreement.
Related trials for Postoperative Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Ryu Komatsu, 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 Postoperative Complications, 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 6 inclusion and 4 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 9 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hypoxemia (time frame: 48 postoperative hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026.