Recruiting

Vital Sign Monitoring

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06232876

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blinded continuous vital sign monitoring

Unblinded continuous vital sign monitoring

Study Details

Brief 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 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.

Conditions

Surgery

Study ID

NCT06232876

Start date

Aug 17, 2026

Status verified date

Aug, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

492 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

sham comparator: Blinded continuous vital sign monitoring

Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.

experimental: Unblinded continuous vital sign monitoring

Continuous ward monitoring with vital signs available to clinicians and investigators.

Interventions

Blinded continuous vital sign monitoring

Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.

Unblinded continuous vital sign monitoring

Continuous ward monitoring with vital signs available to clinicians and investigators.

Primary outcome measure

  • Areas-exceeding-thresholds for desaturation (<85%),4 bradypnea (<7 breaths/min), tachypnea (>30 breaths/min), tachycardia (heart rate >130 beats/min), and bradycardia (heart rate <45 beats/min). [ Time Frame: 48 postoperative hours ]

Central Contacts and Locations

Central contacts

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • monitoring
  • Vital signs
  • Surgery
  • Postoperative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-08-24.