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Continuous Versus Intermittent Ward Monitoring
Sponsor: The University of Texas Health Science Center, Houston
Summary
The investigators will randomize adults having major non-cardiac inpatient surgery to blinded versus unblinded continuous postoperative vital sign monitoring (saturation, ventilation, and heart rate). The investigators will use a wearable, untethered, and battery-powered sensor (Masimo Radius PPG, Masimo, Irvine, CA) that wirelessly connects to a Masimo monitor and continuously records saturation, ventilation, and pulse rate. The primary outcome will be areas-exceeding-thresholds for desaturation (\<85%), bradypnea (\<7 breaths/min), tachypnea (\>30 breaths/min), tachycardia (heart rate \>130 beats/min), and bradycardia (heart rate \<45 beats/min). These exposure thresholds represent a balance between events that are clinically meaningful and excessive alarms that will discourage clinician participation. The investigators expect about 2 alerts per patient per day with these thresholds, with most being considered informative or actionable by nurses. In unblinded patients, clinician alerts will be activated at these thresholds.
Official title: Continuous Versus Intermittent Ward Monitoring on Vital Sign Abnormalities, Clinical Interventions, and Serious Complications: the CONSTANT Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
522
Start Date
2025-11-01
Completion Date
2026-11-01
Last Updated
2025-09-05
Healthy Volunteers
No
Conditions
Interventions
Blinded continuous vital sign monitoring
Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
Unblinded continuous vital sign monitoring
Continuous ward monitoring with vital signs available to clinicians and investigators.
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States