Continuous Versus Intermittent Ward Monitoring

ConditionSurgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

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

492 Participants
are divided into 2 treatment groups

Sponsors and collaborators