Continuous Versus Intermittent Ward Monitoring
Starting soon · Not applicable
Conditions studied: Surgery
In brief
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 1 alert 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.
Key facts
- Study ID
- NCT06232876
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 492
- Starts
- 2026-06-01
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Are admitted to one of the wards equipped with the Masimo Radius PPG and Rad-97 monitors;
- Are ≥18 years old;
- Are designated American Society of Anesthesiologists physical status 1-4;
- Had major noncardiac surgery lasting at least 1.5 hours;
- Are expected to remain hospitalized at least two postoperative nights;
- Had general anesthesia with or without neuraxial anesthesia.
You may not qualify if…
- Have language, vision, or hearing impairments that may compromise continuous monitoring;
- Are designated Do Not Resuscitate, hospice, or receiving end of life care;
- Have previously participated in the study.
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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