Continuous Versus Intermittent Ward Monitoring

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06232876
Status
Recruiting
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Conditions

  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blinded continuous vital sign monitoring — DEVICE
    Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
  • Unblinded continuous vital sign monitoring — DEVICE
    Continuous ward monitoring with vital signs available to clinicians and investigators.

Study Details

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.

Key Dates

First listed
Jan 31, 2024
Start date
Aug 17, 2026
Status verified
Aug 2026
Primary completion
Jul 1, 2028
Completion
Mar 1, 2029

Study Design

Enrollment
492 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Hermann HospitalHoustonTexas77030-
The University of Texas Health Science Center at HoustonHoustonTexas77030
Valerie L Anderson, BS
[email protected]
(713) 500-4383
Daniel I Sessler, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Memorial Hermann Hospital· Houston, TXThe University of Texas Health Science Center at Houston· Houston, TX

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