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.
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.
United States2 sites, 2 recruiting
- Recruiting
Memorial Hermann Hospital
Houston, Texas, 77030
- Not yet 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.
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 group | Role | What they receive |
|---|---|---|
| Blinded continuous vital sign monitoring | Sham comparator | Continuous 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 monitoring | Experimental | Continuous 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.
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)
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.
- First posted31 Jan 2024
- Study start17 Aug 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Principal investigator, Daniel Sessler, The University of Texas Health Science Center, Houston
- Investigators
- Daniel Sessler, MD, Principal investigator, The University of Texas Health Science Center, Houston
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Intermittent Ward Monitoring on Vital Sign Abnormalities, Clinical Interventions, and Serious Complications: the CONSTANT Trial
- ClinicalTrials.gov ID
- NCT06232876
- Acronym / sponsor ID
- CONSTANT / HSC-MS-24-0978
- Conditions
- Surgery
- Keywords
- monitoring, Vital signs, Surgery, Postoperative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded continuous vital sign monitoring | Sham comparator | Device: Blinded continuous vital sign monitoringContinuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators. |
| Unblinded continuous vital sign monitoring | Experimental | Device: Unblinded continuous vital sign monitoringContinuous ward monitoring with vital signs available to clinicians and investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blinded continuous vital sign monitoringContinuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators. | Device | Blinded continuous vital sign monitoring |
| Unblinded continuous vital sign monitoringContinuous ward monitoring with vital signs available to clinicians and investigators. | Device | Unblinded continuous vital sign monitoring |
Primary outcome
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
Area of vital sign abnormalities exceeding defined thresholds.
1 secondary outcome
Interventions
Time frame: 48 postoperative hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Sessler, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
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.