Continuous vs Intermittent Monitoring for Surgery
(CONSTANT Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo continuous or intermittent vital sign monitoring post-surgery using a wearable sensor
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of major complications within 30 days
What Are the Treatments Tested in This Trial?
Interventions
- Blinded Continuous Vital Sign Monitoring
- Continuous Vital Sign Monitoring
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
The University of Texas Health Science Center, Houston
Lead Sponsor
Masimo Corporation
Industry Sponsor
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