Continuous postoperative vital sign monitoring: blinded vs unblinded wearable sensor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing major non-cardiac surgery are randomized to receive continuous postoperative vital sign monitoring with a wearable sensor, either blinded or unblinded to clinicians. The wearable measures oxygen saturation, ventilation, and pulse rate and wires to a monitor for continuous data collection. The trial uses predefined thresholds for desaturation and abnormal respiratory and heart rate events to guide clinician alerts. The goal is to see if visibility of continuous data influences detection and management of deterioration during the early postoperative period. This is a single-center randomized trial comparing two monitoring approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Are admitted to one of the wards equipped with the Masimo Radius PPG and Rad-97 monitors;
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 previously participated in the study.

Where it's running

• Memorial Hermann Hospital
  Houston, Texas, United States Recruiting
• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Daniel Sessler, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Muhammad Omar Naeem, MD
• Email: Muhammad.Omar.Naeem@uth.tmc.edu
• Phone: (713) 500-4383

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.