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โ† Trials
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Continuous Versus Intermittent Ward Monitoring

RecruitingNAAges 18 Years - anyAllThe University of Texas Health Science Center, Hoโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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, w

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Are admitted to one of the wards equipped with the Masimo Radius PPG and Rad-97 monitors; 2. Are โ‰ฅ18 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 previously participated in the study.
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What it tests

  • Blinded continuous vital sign monitoring
  • Unblinded continuous vital sign monitoring
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Where

2 sites
Memorial Hermann Hospital
Houston, United States
The University of Texas Health Science Center at Houston
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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