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NOT YET RECRUITING
NCT06232876
NA

Continuous Versus Intermittent Ward Monitoring

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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

DEVICE

Blinded continuous vital sign monitoring

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

DEVICE

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