Continuous Versus Intermittent Ward Monitoring

NCT ID: NCT06232876

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 522 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-11-01

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.

Detailed Description

Postoperative cardiovascular mortality remains common, and a third occurs during the initial hospitalization. Deterioration occurs over many hours but is usually unrecognized because vital signs are evaluated a 4-6-hour intervals, just as they were a half-century ago when patient acuity was much lower. Recognition of even subtle changes in basic vital signs may allow clinicians to detect cardiopulmonary deterioration well before serious adverse events occur. Consequent clinical interventions may in turn prevent complications, or at least moderate their severity. The investigators therefore propose a single-center randomized trial of continuous ward monitoring.

The investigators will randomize adults having major non-cardiac inpatient surgery to blinded versus unblinded continuous vital sign monitoring (saturation, ventilation, and heart rate) and hourly intermittent blood Postoperative cardiovascular mortality remains common, and a third occurs during the initial hospitalization. Deterioration occurs over many hours but is usually unrecognized because vital signs are evaluated 4-6-hour intervals, just as they were a half-century ago when patient acuity was much lower. Recognition of even subtle changes in basic vital signs may allow clinicians to detect cardiopulmonary deterioration well before serious adverse events occur. Consequent clinical interventions may in turn prevent complications, or at least moderate their severity. The investigators therefore propose a single-center randomized trial of continuous ward monitoring.

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.

Secondarily, the investigators will evaluate a composite of clinical interventions for desaturation, bradypnea, tachypnea, tachycardia, and bradycardia. On an exploratory basis, as a pilot for a future major multi-center outcome trial, The investigators will evaluate a composite of major complications within 30 days after non-cardiac inpatient surgery including rapid response team activation, unplanned intubation, myocardial injury after non-cardiac surgery (MINS), non-fatal cardiac arrest, stroke, sepsis, in-hospital mortality, and hospital readmission.

The innovative long-term goal is to reduce in-hospital postoperative cardiovascular and pulmonary mortality. Specifically, The investigators expect to show that continuous rather than intermittent postoperative vital sign monitoring identifies unstable patients which will allow clinicians to intervene and prevent serious complications and death - thus promoting longer and healthier lives.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Blinded continuous vital sign monitoring

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

Group Type: SHAM_COMPARATOR

Blinded continuous vital sign monitoring

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

Unblinded continuous vital sign monitoring

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Unblinded continuous vital sign monitoring

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Are admitted to one of the wards equipped with the Masimo Radius PPG solution;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Daniel Sessler

Professor and Vice President for Clinical and Outcomes Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Sessler, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Central Contacts

Valerie L Anderson, BS

Role: CONTACT

Valerie.L.Anderson@uth.tmc.edu

(713) 500-4383

Daniel Sessler, MD

Role: CONTACT

Daniel.Sessler@uth.tmc.edu

713-500-3062

Facility Contacts

Valerie L Anderson, BS

Role: primary

Valerie.L.Anderson@uth.tmc.edu

(713) 500-4383

Other Identifiers

HSC-MS-24-0978

Identifier Type: -

Identifier Source: org_study_id