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NCT06232876Not yet recruiting

Continuous Versus Intermittent Ward Monitoring

Continuous Versus Intermittent Ward Monitoring on Vital Sign Abnormalities, Clinical Interventions, and Serious Complications: the CONSTANT Trial
The Cleveland ClinicClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Surgery
Drug/Device/Intervention
Blinded continuous vital sign monitoring
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
The Cleveland Clinic
Location
Cleveland, United States of America
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2024
End date
Mar 01, 2027
Enrollment
492 participants
Primary outcome

Vital sign abnormalities

Summary

We will randomize adults having major non-cardiac inpatient surgery to blinded versus
 unblinded continuous vital sign monitoring (saturation, ventilation, and heart rate) and
 hourly intermittent blood pressure recordings. We will use a wearable, untethered, and
 battery-powered monitor (Masimo Radius VSM, Masimo, Irvine, CA) that continuously records
 saturation, ventilation, and heart rate, and intermittently records blood pressure.
 
 Our primary outcome will be areas-exceeding-thresholds for desaturation (85%),3 bradypnea
 (5 breaths/min), tachypnea (25 breaths/min), tachycardia (heart rate 130 beats/min),
 bradycardia (heart rate 35 beats/min),4 mean arterial pressure (MAP) 65 mmHg, and MAP 145
 mmHg. These exposure thresholds represent a balance between events that are clinically
 meaningful and excessive alarms that will discourage clinician participation. In unblinded
 patients, clinician alerts will be activated at these thresholds.

ICD-10 classifications
Other surgical proceduresSurgical procedure, unspecifiedDuring surgical operationDuring surgical operationDuring surgical operation
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06232876
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06232876 through Pure Global AI's free database. This phase not specified trial is sponsored by The Cleveland Clinic and is currently Not yet recruiting. The study focuses on Surgery. Target enrollment is 492 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.