NCT06232876

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
492

participants targeted

Target at P75+ for not_applicable surgery

Timeline
31mo left

Started Jun 2026

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Mar 2029

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

January 22, 2024

Last Update Submit

May 24, 2026

Conditions

Surgery

Keywords

monitoringVital signsSurgeryPostoperative

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 monitoringDEVICE

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

Blinded continuous vital sign monitoring
Unblinded continuous vital sign monitoringDEVICE

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

Unblinded continuous vital sign monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are admitted to one of the wards equipped with the Masimo Radius PPG and Rad-97 monitors;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Daniel Sessler, MD

CONTACT

713-500-3062Daniel.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

June 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)