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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Near Infrared Spectroscopy for Single Ventricle Heart?

Research suggests that using near-infrared spectroscopy (NIRS) during heart surgery in infants can help predict potential kidney problems and adverse outcomes, which might improve patient monitoring and care. ^{1 2 3 4 5}

Is Near Infrared Spectroscopy (NIRS) safe for use in humans?

Near Infrared Spectroscopy (NIRS) is generally considered safe as it is a noninvasive method used to monitor tissue oxygenation. However, studies have shown that during procedures, some patients experienced adverse events like desaturation and arrhythmia, which were detected by NIRS. It is important to note that these events were related to the medical procedures rather than the use of NIRS itself. ^{6 7 8 9 10}

How does near-infrared spectroscopy treatment differ from other treatments for single ventricle heart conditions?

Near-infrared spectroscopy (NIRS) is unique because it is a non-invasive method that continuously monitors regional tissue oxygenation, allowing real-time assessment of oxygen supply and demand in the body. Unlike other treatments that may focus on direct intervention, NIRS provides valuable information on how well oxygen is being delivered to tissues, which can be crucial for managing patients with single ventricle heart conditions. ^{4 11 12 13 14}

Research Team

Joshua Wong, MD

Principal Investigator

Advocate Children's Hospital

Eligibility Criteria

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.

My infant had a skin injury from a NIR sensor in the hospital.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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 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 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 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]

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]

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 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]

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]

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]

References

1. India 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? [2023]

2. United States 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. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Near-infrared spectroscopy monitoring to predict postoperative renal insufficiency following repair of congenital heart disease. [2014]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Perioperative monitoring in high-risk infants after stage 1 palliation of univentricular congenital heart disease. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Near infrared spectroscopy monitoring in the pediatric cardiac catheterization laboratory. [2014]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Low renal oximetry correlates with acute kidney injury after infant cardiac surgery. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of ventilation modalities on near-infrared spectroscopy in surgically corrected CDH infants. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Cardiac Surgery-Associated Kidney Injury in Children and Renal Oximetry. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Near-infrared spectroscopy as continuous real-time monitoring for kidney graft perfusion. [2021]

12. France pubmed.ncbi.nlm.nih.gov

Near infrared spectroscopy monitoring during pediatric aortic coarctation repair. [2006]

13. United States pubmed.ncbi.nlm.nih.gov

How to Administer Near-Infrared Spectroscopy in Critically ill Neonates, Infants, and Children. [2020]

14. Germany pubmed.ncbi.nlm.nih.gov

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