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Blinded monitoring for Postoperative Complications (COSMOS Trial)
N/A
Recruiting
Led By Daniel I Sessler, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 postoperative hours.
Awards & highlights
COSMOS Trial Summary
This trial aims to see if using a specific mobile monitoring system with nursing alerts can help reduce vital sign problems in patients after major noncardiac surgery.
Who is the study for?
This trial is for adults over 18 who are recovering from major noncardiac surgery that lasted at least 1.5 hours, will stay in the hospital overnight, and had general or neuraxial anesthesia. They should be in a physical condition rated between 1-4 by the American Society of Anesthesiologists.Check my eligibility
What is being tested?
The COSMOS Trial is testing if continuous monitoring with GE Portrait Mobile Monitoring Solution and nurse alerts can reduce post-surgery vital sign abnormalities compared to standard care without constant monitoring.See study design
What are the potential side effects?
Since this trial involves monitoring technology rather than medication, traditional side effects are not expected. However, there may be privacy concerns or potential stress related to continuous vital signs surveillance.
COSMOS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 postoperative hours.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 postoperative hours.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bradycardia and tachycardia
Hypoxemia
Inadequate or excessive ventilation
Secondary outcome measures
The fraction of patients who have a composite of interventions potentially related to postoperative vital sign abnormalities.
COSMOS Trial Design
2Treatment groups
Experimental Treatment
Group I: Unblinded monitoringExperimental Treatment1 Intervention
Continuous postoperative vital sign monitoring unblinded to clinicians and investigators.
Group II: Blinded monitoringExperimental Treatment1 Intervention
Continuous postoperative vital sign monitoring blinded to clinicians and investigators.
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Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,034 Previous Clinical Trials
1,364,569 Total Patients Enrolled
5 Trials studying Postoperative Complications
18,624 Patients Enrolled for Postoperative Complications
Daniel I Sessler, MDPrincipal InvestigatorThe Cleveland Clinic
33 Previous Clinical Trials
96,432 Total Patients Enrolled
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