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SurgeryCONSTANTNCT06232876

Continuous Versus Intermittent Ward Monitoring

A study testing Blinded continuous vital sign monitoring and Unblinded continuous vital sign monitoring in people with Surgery, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery
What is being tested?
Blinded continuous vital sign monitoring and Unblinded continuous vital sign monitoring
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
492 participants
Where
2 sitesUnited States
Study dates
17 Aug 2026to 1 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Muhammad Omar Naeem, MD contact

(713) 500-4383

Muhammad.Omar.Naeem@uth.tmc.edu

Daniel Sessler, MD contact

713-500-3062

Daniel.Sessler@uth.tmc.edu

United States2 sites, 2 recruiting
  • Memorial Hermann Hospital

    Houston, Texas, 77030

    Recruiting
  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

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

    Daniel I Sessler, M.D.

    Not yet recruiting

Other trials in United States

About this study

Official title: Continuous Versus Intermittent Ward Monitoring on Vital Sign Abnormalities, Clinical Interventions, and Serious Complications: the CONSTANT Trial

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.

Read the detailed description

Postoperative cardiovascular mortality remains common, and two-thirds occurs during the initial hospitalization. Deterioration typically occurs over 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 saturation, ventilation, and heart rate monitoring. 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 Rad-97 with Radius PPG Tetherless Pulse oximetry system, Masimo, Irvine, CA) that wirelessly connects to a work station 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 including naloxone administration, rapid-response team activation, unplanned ICU transfer, and mortality within 7 postoperative days.

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
Being tested
Blinded continuous vital sign monitoring, Unblinded continuous vital sign monitoring
Keywords
monitoring, Vital signs, Surgery, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blinded continuous vital sign monitoringDevice

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

  • Unblinded continuous vital sign monitoringDevice

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

Study groups in NCT06232876
Study groupRoleWhat they receive
Blinded continuous vital sign monitoringSham comparatorContinuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
Receives: Device: Blinded continuous vital sign monitoring
Unblinded continuous vital sign monitoringExperimentalContinuous ward monitoring with vital signs available to clinicians and investigators.
Receives: Device: Unblinded continuous vital sign monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Area of vital sign abnormalities exceeding defined thresholds.

    Measured: 48 postoperative hours

Secondary outcomes (1)
  1. Interventions

    The incidence of a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, bradycardia, and hypotension within 48 hours after major non-cardiac surgery.

    Measured: 48 postoperative hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start17 Aug 2026 (estimated)
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
492 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06232876
Sponsor's protocol ID
HSC-MS-24-0978
Acronym
CONSTANT
Status last verified
Aug 2026
First submitted
22 Jan 2024
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Blinded continuous vital sign monitoring and Unblinded continuous vital sign monitoring in people with Surgery, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Muhammad Omar Naeem, MD ((713) 500-4383, Muhammad.Omar.Naeem@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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