Continuous vs Intermittent Monitoring for Surgery

(CONSTANT Trial)

Not yet recruiting at 1 trial location
FR
VL
Daniel Sessler, MD profile photo
Overseen ByDaniel Sessler, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different methods of monitoring vital signs after major non-heart surgeries affect patient care. It compares continuous monitoring with visible data to doctors and a version with hidden data (blinded continuous vital sign monitoring). The goal is to determine if real-time alerts for issues like low oxygen or unusual heart rates improve outcomes. Suitable candidates are adults who have undergone major surgery lasting over 1.5 hours and are staying in the hospital for at least two nights afterward. As an unphased trial, this study allows patients to contribute to innovative research that could enhance post-surgical care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this monitoring technique is safe for surgery patients?

Research shows that patients can usually handle continuous vital sign monitoring with ease. Studies have found that using these monitors in hospital wards can reduce serious health problems. For example, one study discovered that patients with continuous monitoring were less likely to die or need intensive care than those who only had regular check-ups. These devices also alert healthcare staff to issues early on. Few reports of negative effects suggest that this approach is safe for most people.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of continuous vital sign monitoring during surgery, a method that could transform patient care. Unlike the usual practice of intermittent monitoring, which checks patients' vital signs at set intervals, continuous monitoring provides real-time data. The trial investigates both blinded and unblinded methods: in the blinded approach, vital signs are recorded but not shared with patients or clinicians, while in the unblinded approach, this crucial information is available to clinicians, potentially enhancing immediate care decisions. By comparing these methods, researchers hope to determine if continuous monitoring can lead to better patient outcomes and improved safety during surgery.

What evidence suggests that continuous vital sign monitoring is effective for postoperative care?

This trial will compare two approaches to vital sign monitoring during surgery: blinded continuous monitoring and unblinded continuous monitoring. Research has shown that continuous vital sign monitoring can aid patient recovery after major surgeries. One study found that this technology significantly reduced the risk of low oxygen levels and other complications. Another study demonstrated that patients monitored continuously were less likely to require intensive care or encounter life-threatening situations. However, some research suggests that while continuous monitoring increases alerts, it might not always prevent serious changes in vital signs. Overall, evidence indicates that closely watching vital signs can help catch issues early, potentially improving patient safety and recovery.23678

Who Is on the Research Team?

DS

Daniel Sessler, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults undergoing major non-cardiac inpatient surgery. Participants will be using a wearable monitor that tracks vital signs like oxygen levels, breathing rate, and heart rate. It's not clear who can't join because the exclusion criteria are missing.

Inclusion Criteria

I will stay in the hospital for at least two nights after surgery.
I have had surgery under general anesthesia.
My overall health is good enough for surgery.
See 2 more

Exclusion Criteria

I have impairments that could affect my ability to be monitored.
I am under end-of-life care plans like hospice or DNR.
Have previously participated in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo continuous or intermittent vital sign monitoring post-surgery using a wearable sensor

48 hours
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of major complications within 30 days

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Blinded Continuous Vital Sign Monitoring
  • Continuous Vital Sign Monitoring
Trial Overview The study tests two ways of monitoring patients after surgery: one where doctors see the data all the time (unblinded), and another where they don't (blinded). The goal is to see if knowing patient vitals continuously affects outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Unblinded continuous vital sign monitoringExperimental Treatment1 Intervention
Group II: Blinded continuous vital sign monitoringPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Masimo Corporation

Industry Sponsor

Trials
117
Recruited
13,500+

Katie Szyman

Masimo Corporation

Chief Executive Officer

BA from the University of St. Thomas, MBA from Harvard Business School

Dr. Bilal Muhsin

Masimo Corporation

Chief Medical Officer since 2024

MD from Harvard Medical School

Citations

Continuous vital sign monitoring of patients recovering ...This review summarises the history of general ward monitoring and describes future directions, including opportunities to implement these devices using ...
Continuous vital sign monitoring of patients recovering ...This review summarises the history of general ward monitoring and describes future directions, including opportunities to implement these devices using ...
Continuous Vital Sign Monitoring at the Surgical Ward for...Significant reductions in desaturations and adverse events were found, giving evidence to future studies in the use of continuous vital sign monitoring to ...
Impact on Patient Outcomes of Continuous Vital Sign ...A recent propensity-matched study of primary surgical patients found decreased odds of intensive care unit (ICU) admission and mortality in patients receiving ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40591492/
Continuous Vital Sign Monitoring at the Surgical Ward for ...Continuous vital sign monitoring with real-time staff alerts did not significantly reduce cumulative severe vital sign deviations in this ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39779421/
Continuous vital sign monitoring of patients recovering ...Most postoperative deaths occur on general wards, often linked to complications associated with untreated changes in vital signs. Monitoring in these units ...
Continuous Vital Sign Monitoring at the Surgical Ward for ...Continuous wireless vital sign monitoring with real-time alerts may allow for a reduction of vital sign abnormalities and complications. METHODS ...
Impact of continuous and wireless monitoring of vital signs ...Patients who received continuous ward monitoring were less likely to die or be admitted to ICU than those who received intermittent monitoring.
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