Near Infrared Spectroscopy for Single Ventricle Heart

Overseen By JOSHUA WONG, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Advocate Hospital System

Disqualifiers: Over 6 months, Inpatients, Hyperbilirubinemia, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how near infrared spectroscopy (NIRS) can help monitor infants with single ventricle heart disease. Researchers aim to predict when an infant might need to return to the hospital or undergo an intervention by examining how their body uses oxygen. The study also investigates any link between oxygen use and factors like weight gain and brain development. Infants who may qualify for this trial are those under 6 months old with specific heart conditions, not currently hospitalized, and awaiting the Glenn operation. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance monitoring and outcomes for infants with heart conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this technique is safe for use in single ventricle heart patients?

Research has shown that near-infrared spectroscopy (NIRS) is generally safe for people. Studies have found that it effectively checks oxygen levels in the body without causing harm. NIRS can detect early signs of issues like low oxygen (desaturation) and irregular heartbeats (arrhythmia) about 10-15 seconds before symptoms appear, allowing doctors to act quickly.

No reports of serious side effects have emerged from using NIRS. This non-invasive tool sits on the skin and uses light to measure blood oxygen levels. It is considered safe because it doesn't involve needles or cuts. Overall, NIRS offers a promising way to monitor health conditions without adding risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Near Infrared Spectroscopy (NIRS) for single ventricle heart conditions because it offers a non-invasive way to monitor patients' renal health in real time. Unlike traditional methods that might rely on blood tests or imaging to assess kidney function, NIRS uses light to measure tissue oxygenation directly, providing immediate feedback without discomfort. This innovative approach could lead to more responsive and personalized care, potentially improving outcomes for patients with complex heart conditions.

What evidence suggests that near infrared spectroscopy is effective for single ventricle heart?

Research has shown that near-infrared spectroscopy (NIRS), which participants in this trial will use, can help monitor oxygen levels in the body. This is crucial for patients with single ventricle heart conditions. One study found that NIRS could identify low cardiac output, when the heart isn't pumping enough blood, in these patients. This is important because knowing these oxygen levels can help doctors make better treatment decisions. Another study found that NIRS readings were connected to heart function after surgery. These findings suggest that NIRS may be a useful tool for checking heart health in patients with single ventricle conditions. ^{4 6 7 8 9}

Who Is on the Research Team?

Joshua Wong, MD

Principal Investigator

Advocate Children's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with a heart condition known as Single Ventricle Heart. It's specifically looking at patients in the interstage period, which is the time between their first and second heart surgeries.

Inclusion Criteria

My infant is not hospitalized.

My infant is scheduled for the Glenn operation.

My child is younger than 6 months.

Exclusion Criteria

My child is older than 6 months.

My infant has ongoing jaundice.

I am currently hospitalized.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interstage Monitoring

Participants have renal near infrared spectroscopy recorded in clinic to assess oxygen extraction ratio and its correlation with clinical outcomes

1 year

Regular clinic visits

Follow-up

Participants are monitored for safety and effectiveness after the interstage monitoring period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Near Infrared Spectroscopy

Trial Overview The study tests how well renal near infrared spectroscopy (a non-invasive method to monitor oxygen levels in tissues) can predict hospital admissions or interventions during outpatient care in this patient group.

How Is the Trial Designed?

Group I: NIRS use Experimental Treatment 1 Intervention

Patients will have renal near infrared spectroscopy recorded in clinic.

Who Is Running the Clinical Trial?

Advocate Hospital System

Lead Sponsor

Trials

6

Recruited

490+

Published Research Related to This Trial

Near infrared spectroscopy (NIRS) is a noninvasive method that continuously measures cerebral regional oxygen saturation (rSO2), providing valuable information about tissue oxygenation during critical situations like cardiac surgery and resuscitation.

Declines in cerebral NIRS values during cardiac surgery can help reduce major organ morbidity and mortality, while persistently low values during resuscitation indicate a lower likelihood of achieving return of spontaneous circulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Near-infrared spectroscopy during cardiopulmonary resuscitation and mechanical circulatory support: From the operating room to the intensive care unit]. Wally, D., Velik-Salchner, C.[2018]

In a study of 123 pediatric patients undergoing cardiac catheterization, near-infrared spectroscopy (NIRS) effectively monitored tissue oxygenation, revealing that a 9% drop in cranial NIRS values and a 21% drop in renal measurements could indicate potential complications during procedures.

NIRS provided early warning signs for adverse events, such as desaturation and arrhythmia, with changes in NIRS values occurring 10-15 seconds before traditional pulse oximetry, suggesting it could enhance patient safety during interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near infrared spectroscopy monitoring in the pediatric cardiac catheterization laboratory. Tanidir, IC., Ozturk, E., Ozyilmaz, I., et al.[2014]

In a study of 40 infants undergoing heart surgery, those with low renal oximetry (below 50% for more than 2 hours) showed significantly higher peak creatinine levels and a much greater incidence of acute kidney injury (AKI) compared to those with normal oximetry, indicating that NIRS can be a useful tool for early detection of renal dysfunction.

Prolonged low renal oximetry was associated with worse postoperative outcomes, including longer ventilator support and higher lactate levels, suggesting that monitoring renal oximetry could help guide interventions to improve recovery in infants after cardiac surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low renal oximetry correlates with acute kidney injury after infant cardiac surgery. Owens, GE., King, K., Gurney, JG., et al.[2021]

In a study of 59 infants undergoing cardiac surgery, those who developed acute kidney injury (AKI) showed significantly lower renal oximetry values measured by near-infrared spectroscopy (NIRS) both during and after surgery, indicating a potential early warning sign for kidney complications.

The findings suggest that renal NIRS could be a more effective non-invasive monitoring tool for detecting AKI in infants compared to traditional biochemical markers, as prolonged low oximetry values were associated with worse outcomes, including higher lactate levels and increased need for renal replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative renal near-infrared spectroscopy indicates developing acute kidney injury in infants undergoing cardiac surgery with cardiopulmonary bypass: a case-control study. Ruf, B., Bonelli, V., Balling, G., et al.[2022]

In a study of 48 infants undergoing cardiac surgery, intra- and postoperative renal near-infrared spectroscopy (NIRS) monitoring showed a strong correlation with renal insufficiency, particularly on postoperative day 1.

A mean renal saturation below 80% predicted renal insufficiency with 100% sensitivity and 75% specificity, suggesting that NIRS could serve as an early, noninvasive marker for renal issues after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-infrared spectroscopy monitoring to predict postoperative renal insufficiency following repair of congenital heart disease. Colasacco, C., Worthen, M., Peterson, B., et al.[2014]

A study of 162 patients undergoing stage 1 palliation for univentricular heart disease found that high-risk patients (28% of the cohort) had similar operative survival rates compared to standard-risk patients, indicating that intensive monitoring can help achieve comparable early outcomes.

Despite the benefits of enhanced monitoring, high-risk patients experienced lower 1-year survival rates (78% vs 93% for standard-risk) and continued to show increased mortality beyond the initial surgery, highlighting the need for ongoing evaluation of treatment strategies for these vulnerable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative monitoring in high-risk infants after stage 1 palliation of univentricular congenital heart disease. Ghanayem, NS., Hoffman, GM., Mussatto, KA., et al.[2015]

In a study of 91 infants with single-ventricle physiology after stage 1 palliation, cerebral near-infrared spectroscopy (NIRS) values were significantly lower in patients with low cardiac output (LCO) compared to those with normal output, particularly at 1, 6, and 12 hours post-surgery.

Cerebral NIRS values at 6 hours post-surgery were found to be a reliable indicator for detecting LCO, with a cut-off value of ≤57% showing 91% sensitivity and 72% specificity, although NIRS did not predict other adverse outcomes like cardiac arrest or mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there an association of near-infrared spectroscopy with low cardiac output and adverse outcomes in single-ventricle patients after stage 1 palliation? Doctor, P., Aggarwal, S., Garcia, R.[2023]

In a study of 20 children after congenital heart surgery, near-infrared spectroscopy (NIRS) was used to monitor splanchnic and renal oxygenation, but it showed low sensitivity (48%) and moderate specificity (67%) for detecting low cardiac output.

The analysis indicated that neither splanchnic nor renal NIRS events were reliable predictors of low cardiac output, suggesting that NIRS may not be an effective tool for monitoring this condition in pediatric patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in regional (somatic) near-infrared spectroscopy is not a useful indicator of clinically detectable low cardiac output in children after surgery for congenital heart defects. Bhalala, US., Nishisaki, A., McQueen, D., et al.[2022]

Near-infrared spectroscopy (NIRS) effectively monitors regional oxygenation (rSO(2)) in kidney grafts, showing a significant increase in rSO(2) from a median of 68.8% to 83.6% over 72 hours post-transplantation in a study of 24 children.

The study found strong correlations between rSO(2) values and kidney function markers such as serum creatinine and estimated glomerular filtration rate (eGFR), indicating that NIRS can provide real-time insights into kidney graft perfusion and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-infrared spectroscopy as continuous real-time monitoring for kidney graft perfusion. Vidal, E., Amigoni, A., Brugnolaro, V., et al.[2021]

In a study of 13 infants with congenital diaphragmatic hernia (CDH) undergoing surgery, both cerebral and splanchnic oxygenation significantly decreased during the procedure, indicating a potential risk for oxygen deprivation in these patients.

Infants receiving high-frequency oscillatory ventilation (HFOV) experienced a longer recovery time for normal cerebral oxygenation compared to those on conventional mechanical ventilation (CMV), suggesting that HFOV may negatively affect hemodynamics and cardiac output during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ventilation modalities on near-infrared spectroscopy in surgically corrected CDH infants. Conforti, A., Giliberti, P., Landolfo, F., et al.[2018]

Near infrared spectroscopy (NIRS) is a non-invasive method that measures regional tissue oxygenation (rSO2) by analyzing the absorption of light by oxygenated and deoxygenated hemoglobin, allowing for early detection of changes in oxygen supply or demand before vital signs change.

NIRS is currently used in clinical settings to monitor oxygenation during and after cardiac surgery, as well as in vulnerable newborns, and has potential for broader applications in neuromonitoring and other medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Administer Near-Infrared Spectroscopy in Critically ill Neonates, Infants, and Children. Bruns, N., Moosmann, J., Münch, F., et al.[2020]

In a study of children undergoing cardiac surgery, 65% experienced acute kidney injury, and lower baseline renal oxygen saturation was linked to a decreased risk of this injury, suggesting that maintaining adequate oxygen delivery may protect the kidneys during surgery.

The study found that children with higher baseline renal oxygen saturation were 7.14 times more likely to develop acute kidney injury, indicating that monitoring and optimizing renal oxygen levels could be crucial in preventing kidney damage during cardiac procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Surgery-Associated Kidney Injury in Children and Renal Oximetry. Joffe, R., Al Aklabi, M., Bhattacharya, S., et al.[2019]

Monitoring cerebral and renal oxygen levels using near-infrared spectroscopy (NIRS) during congenital cardiac surgery can help predict serious outcomes like ECMO or death, especially when NIRS values fall below 45% for cerebral and 40% for renal.

The study found that lower renal NIRS values (below 30%) are associated with longer stays in the intensive care unit, indicating that NIRS can be a useful tool for assessing patient recovery post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of perioperative near-infrared spectroscopy during neonatal and infant congenital heart surgery for adverse in-hospital clinical events. Dodge-Khatami, J., Gottschalk, U., Eulenburg, C., et al.[2014]

In a study of 26 pediatric patients undergoing aortic coarctation repair, near infrared spectroscopy (NIRS) effectively monitored real-time changes in regional oxygenation, revealing significant declines in oxygen levels below the aortic cross-clamp, especially in neonates and infants under 1 year.

The greater decline in oxygenation in younger patients suggests they have less collateral circulation, indicating a higher risk of impaired regional perfusion during surgery compared to older children, who showed only minor changes in oxygen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near infrared spectroscopy monitoring during pediatric aortic coarctation repair. Berens, RJ., Stuth, EA., Robertson, FA., et al.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9802614/

Is there an association of near-infrared spectroscopy with low ... Our primary objective study was to evaluate the association between near-infrared spectroscopy (NIRS) and low cardiac output (LCO) in patients with single- ...

2. journals.lww.com journals.lww.com/aopc/fulltext/2022/15030/is_there_an_association_of_near_infrared.4.aspx

Is there an association of near-infrared spectroscopy with... In our study, cerebral NIRS values at 6 h were independently associated with LCO in the early postoperative period in patients with single ventricle physiology.

3. withpower.com withpower.com/trial/phase-univentricular-heart-6-2024-e4107

Near Infrared Spectroscopy for Single Ventricle Heart The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period.

4. sciencedirect.com sciencedirect.com/science/article/pii/S000709121733859X

Near-infrared spectroscopy as an index of brain and tissue ... NIR light can be used to measure regional cerebral tissue oxygen saturation (rSO 2 ). This technique uses principles of optical spectrophotometry.

5. jtcvs.org jtcvs.org/article/S0022-5223(05)01277-8/fulltext

Near-infrared spectroscopy to monitor cerebral oxygen ... This study explores the relationship between cerebral oxygen saturation, jugular venous oxygen saturation, and other variables of cerebral perfusion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11979500/

Near-infrared spectroscopy to monitor cerebral and renal ... This study aims to investigate the associations between intraoperative cerebral/renal rSO₂ fluctuations monitored by NIRS and postoperative ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00464100

Study Details | NCT00464100 | Near-infrared Spectroscopy ... Postoperative monitoring of venous oximetry and, more recently, near infrared spectroscopy, have identified periods of impaired oxygen delivery and ischemia, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0022522308013020

Congenital heart disease Near-infrared spectroscopy ... Near-infrared spectroscopy may provide a real-time window into cerebral oxygenation. Enthusiasm for near-infrared spectroscopy has increased hopes of reducing ...

9. jtcvs.org jtcvs.org/article/S0022-5223(08)01302-0/pdf

Near-infrared spectroscopy: What we know and what ... Although near-infrared spectroscopy has promise for measuring regional tissue oxygen saturation, the lack of data demonstrating improved outcomes limits the ...