Cerebral Monitoring for Cardiac Surgery Outcomes

Overseen By G. Burkhard Mackensen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Stroke, Cerebral vascular disease, Pregnancy, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Surgery and immediate post-operative period (up to 24 hours post-surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a brain monitor during heart surgery can reduce post-surgery thinking and memory problems. It compares patients using the brain monitor to those receiving usual care. This study may suit adults undergoing heart surgery with a heart-lung machine, such as bypass or valve procedures. The goal is to improve recovery and quality of life after surgery. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

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 study team or your doctor.

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

Research has shown that cerebral oximetry monitoring during heart surgery is generally safe and well-tolerated. A study that combined results from multiple trials found that this monitoring led to fewer cases of memory and thinking problems post-surgery, suggesting it helps protect the brain during operations without causing additional harm.

Cerebral oximetry, a type of optical monitoring, is safe and non-invasive, meaning it doesn't involve surgery or entering the body, which reduces risks for patients. Although detailed safety data from this specific trial is not yet available, previous studies have demonstrated that this method is reliable and doesn't cause significant side effects.

Overall, existing research suggests that using a cerebral monitor during surgery is a safe option and may help reduce the risk of brain-related issues after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cerebral Monitor Guided Therapy because it offers a new way to improve outcomes in cardiac surgery by closely monitoring and maintaining cerebral oxygen levels. Unlike standard care, which often relies on the physician's discretion without specific cerebral monitoring, this approach uses real-time cerebral oximetry to ensure brain oxygenation stays above a critical threshold. This method aims to prevent potential brain damage during surgery by adjusting factors like oxygen levels, blood pressure, and blood flow, promising a more tailored and potentially safer surgical experience.

What evidence suggests that cerebral monitor guided therapy is effective for improving cardiac surgery outcomes?

This trial will compare cerebral monitoring guided therapy with standard care during cardiac surgery. Research has shown that monitoring the brain during heart surgery helps manage oxygen levels in the brain. Studies indicate that this approach can improve blood flow to the brain, which is crucial during surgery. One study found that near-infrared spectroscopy effectively checks if the brain receives enough blood and oxygen. This method allows for quick adjustments during surgery to prevent brain damage. By closely monitoring brain oxygen levels, this approach aims to reduce the risk of brain and memory problems after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Kei Togashi, MD MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adult cardiac surgery patients who will undergo procedures involving cardiopulmonary bypass and heart arrest, like bypasses or valve replacements. It's not for those with recent strokes, severe artery narrowing in the brain, extremely high surgical risk as judged by doctors, a BMI over 50, pregnancy, certain psychiatric conditions or cognitive issues that affect study compliance, uncontrolled infections, liver disease indicated by enzyme tests, participation in other conflicting studies or refusal to enroll.

Inclusion Criteria

I am an adult scheduled for heart surgery involving a heart-lung machine and stopping my heart.

Exclusion Criteria

Institution inmates

Participation in any other clinical investigation that is likely to confound study results or affect study outcome

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery with cerebral oximetry monitoring and metabolomic profiling

Surgery and immediate post-operative period (up to 24 hours post-surgery)

In-hospital stay for surgery and monitoring

Follow-up

Participants are monitored for neurocognitive outcomes and metabolomic changes

6 weeks

Follow-up visits at discharge and 6 weeks post-operation

Post-operative ICU Stay

Neurologic clinical testing during the acute post-operative ICU stay

Up to 2 weeks post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Cerebral Monitor Guided Therapy

Trial Overview The study aims to see if using a cerebral oxygen monitor during and after heart surgery can improve brain function outcomes compared to standard care. Researchers will compare metabolomic profiles (which are like chemical fingerprints of metabolism) between the two groups to assess the impact on neurological health and quality of life post-surgery.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

* Maintain rSO2 values at or above 75% of the baseline * Midline position * Target CO2 of ≥40 mmHg, target MAP \>60 mm Hg * Maintain cerebral perfusion pressure \>50 mm Hg * Target pump flow 2.5 L/m2/min * If rSO2 persistently below treatment threshold: * FiO2 is increased * or propofol 50-100 mg bolus is administered * If Hct below 20% packed red blood cells will be transfused timeline: before induction, after time-out has been performed, and will continue until 24 hours post surgery.

Group II: Control Group Active Control 1 Intervention

Patients in the control group will be managed under the attending physician's discretion. Cerebral oximetry data will be collected in the same fashion as in the intervention group, but the measurements will be blinded to the physician. Blood samples will be collected for metabolomic profiling in the same fashion and at identical time points as the intervention group for later analysis.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03316183

Study Details | NCT03316183 | Cerebral Monitor Guided ... The purpose of this study is to compare patients' metabolomic profiles who are managed with a brain monitor that measures cerebral oxygen to those who are ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23267000/

Cerebral near-infrared spectroscopy monitoring and ... - PubMed Near-infrared spectroscopy is used during cardiac surgery to monitor the adequacy of cerebral perfusion.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1053077021006108

Neuromonitoring and Neurocognitive Outcomes in Cardiac ... This review focuses on the use of cerebral monitoring and clinical outcomes in cardiac surgery, incorporating the most recent evidence.

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/results/NCT03316183

No Study Results Posted | Cerebral Monitor Guided Therapy on ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

5. openheart.bmj.com openheart.bmj.com/content/11/2/e002939

Intraoperative neurophysiologic monitoring during cardiac ... This study suggests that IONM may be safely used in the intraoperative setting, and it may provide actionable neurologic data for intervening ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9732949/

The Use of Cerebral Oximetry in Cardiac Surgery In this meta-analysis, the use of cerebral oximetry monitoring in cardiac surgery demonstrated a lower incidence of postoperative cognitive dysfunction.

7. jcvaonline.com jcvaonline.com/article/S1053-0770(25)00212-5/fulltext

Cerebral Autoregulation Monitoring: Time to Prioritize the ... The impact of blood pressure below personalized lower cerebral autoregulation limit on outcomes after cardiac surgery: A retrospective study.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7587277/

Optical monitoring of cerebral perfusion and metabolism in ... Optical neuromonitoring provides a safe and non-invasive approach for assessing intraoperative perfusion and metabolism and has potential in ...