Continuous Versus Intermittent Ward Monitoring on Vital Sign Abnormalities, Clinical Interventions, and Serious Complications: the CONSTANT Trial
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.
Description
Postoperative cardiovascular mortality remains common, and a third occurs during the initial hospitalization. Deterioration occurs over many hours but is usually unrecognized because vital signs are evaluated a 4-6-hour intervals, just as they were a half-century ago when patient acuity was much lower. Recognition of even subtle changes in basic vital signs may allow clinicians to detect cardiopulmonary deterioration well before serious adverse events occur. Consequent clinical interventions may in turn prevent complications, or at least moderate their severity. The investigators therefore pro…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Are admitted to one of the wards equipped with the Masimo Radius PPG solution; 2. Are ≥18 years old; 3. Are designated American Society of Anesthesiologists physical status 1-4; 4. Had major noncardiac surgery lasting at least 1.5 hours; 5. Are expected to remain hospitalized at least two postoperative nights; 6. Had general anesthesia with or without neuraxial anesthesia. Exclusion Criteria: 1. Have language, vision, or hearing impairments that may compromise continuous monitoring; 2. Are designated Do Not Resuscitate, hospice, or receiving end of life care; 3. Have…
Interventions
- DeviceBlinded continuous vital sign monitoring
Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
- DeviceUnblinded continuous vital sign monitoring
Continuous ward monitoring with vital signs available to clinicians and investigators.
Location
- The University of Texas Health Science Center at HoustonHouston, Texas