Continuous Versus Intermittent Ward Monitoring

NCT06232876 | Not Yet Recruiting FDA Device

• 1 other identifier: HSC-MS-24-0978
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 1

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 2 alerts 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

Outcome Measures

Primary Outcomes (1)

• Vital sign abnormalities with routine hospital monitors

  Area of vital sign abnormalities exceeding defined thresholds.

  48 postoperative hours

Secondary Outcomes (1)

• Interventions

  48 postoperative hours

Study Arms (2)

Blinded continuous vital sign monitoring

SHAM COMPARATOR

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

Device: Blinded continuous vital sign monitoring

Unblinded continuous vital sign monitoring

EXPERIMENTAL

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

Device: Unblinded continuous vital sign monitoring

Interventions

Blinded continuous vital sign monitoring DEVICE

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

Blinded continuous vital sign monitoring

Unblinded continuous vital sign monitoring DEVICE

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

Unblinded continuous vital sign monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are admitted to one of the wards equipped with the Masimo Radius PPG solution;
• Are ≥18 years old;
• Are designated American Society of Anesthesiologists physical status 1-4;
• Had major noncardiac surgery lasting at least 1.5 hours;
• Are expected to remain hospitalized at least two postoperative nights;
• Had general anesthesia with or without neuraxial anesthesia.

You may not qualify if:

• Have language, vision, or hearing impairments that may compromise continuous monitoring;
• Are designated Do Not Resuscitate, hospice, or receiving end of life care;
• Have previously participated in the study.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Masimo Corporation: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

• Daniel Sessler, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie L Anderson, BS

CONTACT

(713) 500-4383; Valerie.L.Anderson@uth.tmc.edu

Daniel Sessler, MD

CONTACT

713-500-3062; Daniel.Sessler@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice President for Clinical and Outcomes Research

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)