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Procedure

Unblinded continuous monitoring for Surgery (CONSTANT Trial)

N/A

Waitlist Available

Led By Daniel 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

Expected to remain hospitalized at least two postoperative nights

Had general anesthesia with or without neuraxial anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 postoperative hours.

Awards & highlights

CONSTANT Trial Summary

This trial will involve adults who are having major surgery but not related to the heart. The participants will be randomly assigned to either receive continuous monitoring of their vital signs (such as oxygen levels, breathing rate

Who is the study for?

This trial is for adults undergoing major non-cardiac inpatient surgery. Participants will be using a wearable monitor that tracks vital signs like oxygen levels, breathing rate, and heart rate. It's not clear who can't join because the exclusion criteria are missing.Check my eligibility

What is being tested?

The study tests two ways of monitoring patients after surgery: one where doctors see the data all the time (unblinded), and another where they don't (blinded). The goal is to see if knowing patient vitals continuously affects outcomes.See study design

What are the potential side effects?

Since this trial involves monitoring with a wearable device rather than medication, traditional side effects aren't expected. However, there may be discomfort or skin irritation from wearing the device.

CONSTANT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will stay in the hospital for at least two nights after surgery.

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I have had surgery under general anesthesia.

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My overall health is good enough for surgery.

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I am 18 years old or older.

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I had a major surgery that lasted more than 1.5 hours.

CONSTANT 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

Vital sign abnormalities

Secondary outcome measures

Interventions

CONSTANT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Unblinded continuous monitoringExperimental Treatment1 Intervention

Continuous ward monitoring with vital signs available to patients, clinicians, and investigators.

Group II: Blinded continuous monitoringPlacebo Group1 Intervention

Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,365,584 Total Patients Enrolled

13 Trials studying Surgery

72,312 Patients Enrolled for Surgery

Daniel Sessler, MDPrincipal InvestigatorThe Cleveland Clinic

4 Previous Clinical Trials

389 Total Patients Enrolled

1 Trials studying Surgery

100 Patients Enrolled for Surgery

Frequently Asked Questions

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

Are there any available positions for patients in this ongoing clinical trial?

"Based on the information available on clinicaltrials.gov, it appears that this study is not actively recruiting participants. The trial was posted on March 1st, 2024 and last updated on January 22nd, 2024. However, there are currently a total of 240 other ongoing clinical trials seeking eligible patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Continuous Versus Intermittent Ward Monitoring

2024. "Continuous Versus Intermittent Ward Monitoring". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06232876.