About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Blinded continuous vital sign monitoring
- Unblinded continuous vital sign monitoring
Treatment groups
Sponsors and collaborators
The University of Texas Health Science Center, Houston
Lead sponsor
Masimo Corporation
Collaborator