Continuous Versus Intermittent Ward Monitoring (NCT06232876)
Continuous Versus Intermittent Ward Monitoring on Vital Sign Abnormalities, Clinical Interventions, and Serious Complications: the CONSTANT Trial
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Memorial Hermann Hospital โ Houston, Texas
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- Memorial Hermann Hospital โ Houston, Texas
- The University of Texas Health Science Center at Houston โ Houston, Texas
๐ Contact the Study Coordinator
Phone: (713) 500-4383
Email: Muhammad.Omar.Naeem@uth.tmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Surgery
- Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 Trial โ Hamilton, Ontario
- Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites โ Boston, Massachusetts
- Circadian Rhythm Disruption in the Hospital Intensive Care Environment โ Philadelphia, Pennsylvania
- Operating Room Air Filtration/Sterilization โ Cleveland, Ohio
- Preparing Older Adults for Major Surgery With Preoperative Comprehensive Geriatric Assessments โ Madison, Wisconsin
- Differences in Radial and Ulnar Artery Size in Young Children โ Columbus, Ohio
Explore by condition: All Surgery clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.