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Unblinded 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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 postoperative hours. for reporting.

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,364,702 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this clinical trial currently open?

"According to information provided on clinicaltrials.gov, patient recruitment is ongoing for this trial. The study was initially listed on 2/14/2024 and most recently modified on 3/18/2024."

Answered by AI

What is the current number of participants who are being recruited for this research study?

"Affirmative. Information available on clinicaltrials.gov highlights that this research endeavor is actively seeking eligible individuals to participate. The trial was initially listed on February 14, 2024, with the most recent update noted on March 18, 2024. A total of 856 participants are being sought at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06133140.