The Inadequate Oxygen Delivery Index and its Correlation with Venous Saturation in the Pediatric Cardiac Intensive Care Unit

doi:10.21203/rs.3.rs-3193241/v1

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Research Article

The Inadequate Oxygen Delivery Index and its Correlation with Venous Saturation in the Pediatric Cardiac Intensive Care Unit

https://doi.org/10.21203/rs.3.rs-3193241/v1

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Journal Publication

published 24 Sep, 2023

Read the published version in Pediatric Cardiology →

You are reading this latest preprint version

Background

Continuous monitoring software, T3, has an integrated index called the inadequate oxygen delivery index 50% (IDO2-50%) which displays a probability that the mixed venous saturation is below a user-selected threshold of 30–50%. The primary aim of this study was to determine the correlation of the IDO2-50% with a measured venous saturation. The secondary aim of this study was to characterize the hemodynamic factors that contributed to the IDO2-50%.

Methods

This single-center, retrospective study aimed to characterize the correlation between IDO2-50% and inferior vena cava (IVC) saturation. A Bayesian Pearson correlation was conducted to assess the correlation between the collected variables of interest, with a particular interest in the correlation between the IDO2-50% and the IVC saturation. Receiver operator curve (ROC) analysis to assess the ability of the IDO2-50% to identify when the venous saturation was less than 50%. Bayesian linear regression was done with the IDO2-50% (dependent variable) and other independent variables.

Results

A total of 113 datasets were collected across 15 unique patients. IDO2-50% and the IVC saturation had moderate correlation with the IVC saturation (correlation coefficient − 0.569). The IDO2-50% had a weak but significant correlation with cerebral near infrared spectroscopy (NIRS) values, a weak but significant correlation with heart rate, and a moderate and significant correlation with arterial saturation. ROC analysis demonstrated that the IDO2-50% had a good ability to identify a venous saturation below 50%, with an area under the curve of 0.797, cutoff point of 24.5 with a sensitivity of 81%, specificity of 66%, positive predictive value of 44% and negative predictive value of 91%. Bayesian linear regression analysis yielded the following model: 237.82 + (1.18 x age in months) – (3.31 x arterial saturation) – (1.92 x cerebral NIRS) + (0.84 x heart rate).

Conclusion

The IDO2 index has moderate correlation with IVC saturation. It has good sensitive and negative predictive value. Cerebral NIRS does appear to correlate better with the underlying venous saturation than the IDO2 index.

pediatrics

children

intensive care unit

inadequate oxygen delivery

oxygen saturation

congenital heart defects

The care of critically ill children requires close hemodynamic monitoring. While clinical morbidity and mortality have been demonstrated to be linked to oxygen delivery, most conventionally monitored hemodynamic parameters are not directly related to systemic oxygen delivery and its components of cardiac output and oxygen content [1].

Monitoring oximetric indices in critically ill children can provide benefit of early detection of morbidity and mortality and facilitate early intervention [2–16]. Such monitoring requires monitoring of the venous saturation which is most effectively done by placing a venous catheter. These are invasive, however, and blood gases are associated with cost. Noninvasive methods have now been developed such as near infrared spectroscopy. Continuous monitoring software, T3, has an integrated index called the inadequate oxygen delivery (IDO2) index which displays a probability that the mixed venous saturation is below a user-selected threshold of 30%, 40%, or 50%. Thus, as the mixed venous saturation is decreasing, the selected index value should be increasing. This index is calculated by use of several monitored inputs, many of which are noninvasive.

The primary aim of this study was to determine the correlation of the IDO2 index 50% (IDO2-50%) with a measured venous saturation. The secondary aim of this study was to characterize the hemodynamic factors that contributed to the IDO2-50%.

Study design

This study protocol was approved by the institutional review board. It is in concordance with the Helsinki Declaration. This study was a single-center, retrospective study aimed to characterize the correlation between the IDO2-50% and inferior vena cava (IVC) saturation.

Variables of interest

The variables of interest collected were as follows: IDO2-50%, venous saturation, heart rate, mean arterial blood pressure, arterial saturation by pulse oximetry, cerebral near infrared spectroscopy, and renal near infrared spectroscopy. The presence or absence of a functionally univentricular heart was also collected. Functionally univentricular hearts were defined as those with parallel circulation, Glenn circulation, or Fontan circulation. Parallel circulation was defined as any circulation in which the saturation of blood going to the pulmonary and systemic circulations was equal.

The IDO2 index is calculated by the T3 software. This index is a continuous estimation of the likelihood that a patient currently has a mixed venous saturation that is below a certain threshold. The T3 software allows for this threshold to be set at either 30, 40, or 50, thus resulting in a probability that the patient's mixed venous saturation is under the specified threshold. For example, if the IDO2-50% is 15, this would imply a probability of 15% that the mixed venous saturation at the time is less than 50%. The number is derived by use of a vital signs and laboratory data that are collected by the software and then applying use of physiology-based models and advanced algorithms.

Venous saturations were obtained by use of femoral lines terminating in the IVC. Line placement was confirmed by radiographs.

Two- site near infrared spectroscopy values were collected. A cerebral and renal value were collected. Near infrared spectroscopy values were obtained using the Casmed ForeSight Elite tissue oximeter.

Heart rate, mean arterial blood pressure, arterial saturation by pulse oximetry, cerebral near infrared spectroscopy, and renal near infrared spectroscopy were collected as an average of these values for the 20 minutes preceding when the venous saturation was obtained. The IDO2-50% was also collected as an average of the 20 minutes preceding the venous saturation. Data, such as the IDO2-50% was collected in this manner as to help lend insight into how the index correlates with the venous saturation prior to that data being available to T3 to incorporate into the calculation of the value. T3 captures these data in high fidelity in continuous fashion.

The values of interest were all purposefully selected such that they are utilized by the software in calculating the IDO2-50% and may be obtained noninvasively.

Patient inclusion

Pediatric patients under 18 years of age who were cared for in the cardiac intensive care unit between September 1, 2022, and December 31, 2022, were eligible for inclusion. The starting date in this range coincides with when T3 was implemented at the institution. Only patients in whom an IVC saturation was obtained were eligible for inclusion. Data was only included if collected while not on mechanical circulatory support. Data points were only included if the IDO2-50% was available for the 20 minutes preceding the venous saturation, otherwise they were excluded.

Statistical analyses

Continuous variables were reported as mean and standard deviation while categorical variables were reported as absolute frequency and percentage. A Bayesian Pearson correlation was conducted to assess the correlation between the collected variables of interest, with a particular interest in the correlation between the IDO2-50% and the IVC saturation.

A receiver operator curve analysis was then done to assess the ability of the IDO2-50% to identify when the venous saturation was less than 50%.

Next, a Bayesian linear regression was done with the IDO2-50% as the dependent variable and the following independent variables: functionally univentricular heart, age in months, arterial saturation by pulse oximetry, cerebral near infrared spectroscopy, renal near infrared spectroscopy, heart rate, and mean arterial pressure. The regression analysis utilized the Jeffreys-Zellner-Siow prior.

Bayesian statistics were utilized rather than frequentist regressions for several reasons. The details of these are beyond the scope of this manuscript but in general Bayesian statistics allows for generating a distribution for all point estimates. This allows for the quantification of the probability of specific outcomes and models describing the outcomes. Bayesian models have also been demonstrated to be more well-fitted and reproducible.

Statistical analyses were conducted utilizing SPSS Version 29.0 (IBM corporation). Bayes factors are presented throughout the text. P-values are not presented as Bayesian statistical tools and not frequentist statistical tools were utilized.

Cohort information

A total of 113 datasets were collected across 15 unique patients. Datasets, rather than patients, were treated as individual subjects. As such, the median age was 7 months. Of the 113 data points, 73 (65%) were from those with functionally univentricular hearts all of which had parallel circulation. Thus, there were none with Glenn or Fontan circulations. Of the 113 data points, 3 (3%) had transposition physiology.

Correlation of the IDO2-50% and the IVC saturation

When all data were analyzed, the IDO2-50% and the IVC saturation had moderate correlation with the IVC saturation (correlation coefficient − 0.569, Bayes Factor₁₀ > 100) (Table 1).

Table 1

Correlations between the inadequate oxygen delivery index 50 and several hemodynamic parameters (all patients and in those with parallel circulation only).
	Inferior caval vein saturation	Cerebral near infrared spectroscopy	Renal near infrared spectroscopy	Heart rate	Arterial saturation by pulse oximetry	Mean arterial pressure
Inadequate oxygen delivery index 50 (all patients)	-0.569^c	-0.481^a	-0.286	0.373^c	-0.559^c	-0.174
Inadequate oxygen delivery index 50 (those with parallel circulation only)	-0.524^c	-0.449	-0.177	0.209	-0.521^c	0.042
^aBayes Factor 10 > 10; ^bBayer Factor 10 > 30; ^cBayes Factor 10 > 100.

When only data from those without parallel circulation were analyzed, the IDO2-50% and the IVC saturation had moderate correlation with the IVC saturation (correlation coefficient − 0.524, Bayes Factor₁₀ > 100) (Table 1).

Correlation of the IDO2-50% and other hemodynamic parameters

When all data were analyzed, the IDO2-50% had a weak but significant correlation with cerebral near infrared spectroscopy values, a weak but significant correlation with heart rate, and a moderate and significant correlation with arterial saturation (Table 1).

When only data from those with parallel circulation were analyzed, the IDO2-50% had a moderate and significant correlation with arterial saturation (Table 1).

Correlation of the IVC saturation with near infrared spectroscopy

To help frame the correlations of the IDO2-50% and IVC saturation, correlations were also calculated for near infrared spectroscopy and IVC saturation.

When all data were analyzed, cerebral near infrared spectroscopy had a strong and significant correlation with IVC saturation and renal near infrared spectroscopy had a weak but significant correlation with IVC saturation (Table 2).

Table 2

Correlation of the inferior caval vein saturation with near infrared spectroscopy (all patients and in those with parallel circulation only).
	Inferior caval vein saturation
Cerebral near infrared spectroscopy (all patients)	0.712^c
Renal near infrared spectroscopy (all patients)	0.375^b
Cerebral near infrared spectroscopy (those with parallel circulation only)	0.703^c
Renal near infrared spectroscopy (those with parallel circulation only)	0.182
^aBayes Factor 10 > 10; ^bBayer Factor 10 > 30; ^cBayes Factor 10 > 100.

When only data from those with parallel circulation were analyzed, cerebral near infrared spectroscopy had a strong and significant correlation with IVC saturation (Table 2).

Receiver operator curve analysis

Receiver operator curve analysis demonstrated that the inadequate delivery of oxygen index 50 had a good ability to identify a venous saturation below 50%. The area under the curve for this was 0.797. The optimal cutoff point was 24.5. This cutoff resulted in a sensitivity of 81% and specificity of 66%. This cutoff had a positive predictive value of 44% and a negative predictive value of 91%.

Regression analysis of the IDO2-50%

Bayesian linear regression analysis yielded a model with a Bayes Factor₁₀ of 99 and an R-squared value of 0.751. The model included the following independent variables: age in months, arterial saturation by pulse oximetry, cerebral near infrared spectroscopy, and heart rate.

The resulting equations was as follows: 237.82 + (1.18 x age in months) – (3.31 x arterial saturation) – (1.92 x cerebral near infrared spectroscopy) + (0.84 x heart rate).

To simplify the associations demonstrated in this regression model, the IDO2-50% increases with increasing age, decreases with increasing arterial saturation, decreases with increases cerebral near infrared spectroscopy, and increases with increasing heart rate.

The current study demonstrates that the IDO2-50% has moderate and significant correlation with the IVC saturation. This remained the case in subset analysis of only data from those with parallel circulation. When compared to near infrared spectroscopy, the IDO2-50% outperformed renal near infrared spectroscopy but not cerebral near infrared spectroscopy in identifying those with an IVC saturation of less than 50. The IDO2-50% has good sensitivity and negative predictive value. Thus, a low IDO2-50% appears to be reassuring while a high IDO2-50% is often present when the IVC saturation is still greater than 50.

These novel data serve as the first publicly available, independent data comparing the IDO2-50% to a measured venous saturation. These are important data as the IDO2-50% is developed to predict the probability that the mixed venous saturation is below 50. It is infrequent that a true mixed venous saturation is available in clinical use although it is much more likely that a central venous saturation is available. Previous data have demonstrated that both the superior vena cava (SVC) and IVC saturation significantly trend with the mixed venous saturation and that the IVC saturation may provide some enhanced ability to discern adverse clinical outcomes when compared to the SVC saturation [15–17]. Due to this, it was felt that characterizing the relationship between the IDO2-50% and the IVC saturation would be of importance. As the venous saturation decreases, the IDO2-50% should increase and as the venous saturation increases, the IDO2-50% should decrease. Although more institutions have implemented T3 into their clinical workflow, this important phenomenon has not truly been demonstrated objectively.

But why is such a surrogate marker of the venous saturation even necessary? As the human body requires oxygen to function, morbidity and mortality increases with decrease in systemic oxygen delivery. This has been demonstrated regionally with decrease in regional venous saturation or increase in regional oxygen extraction ratio being associated with morbidity such as neurodevelopmental delay, necrotizing enterocolitis, acute kidney injury, and liver injury in those with and without congenital heart disease [14, 18–26]. Conventional hemodynamic parameters such as heart rate, arterial saturation, and blood pressure have been demonstrated to be unable to effectively reflect systemic oxygen delivery [1]. Thus, other metrics must be sought. Systemic oxygen delivery is the product of cardiac output and oxygen content. Cardiac output is quantified by the Fick equation which demonstrates that cardiac output is the quotient of oxygen consumption and the arteriovenous oxygen content difference. Oxygen content is the function of hemoglobin and arterial saturation. Thus, systemic oxygen delivery includes hemoglobin, arterial saturation, venous saturation, oxygen consumption, and the partial pressure of oxygen. From this it becomes apparent why conventional hemodynamic monitoring does not adequately reflect systemic oxygen delivery. Oft-used blood pressure is the product of flow and systemic vascular resistance and unless one can monitor systemic vascular resistance it is not possible to know to what degree changes in blood pressure are due to systemic cardiac output rather than systemic vascular resistance. This, however, is a critical distinction as only systemic cardiac output contains oxygen not systemic vascular resistance. Thus, achieving arbitrary blood pressure goals by increasing systemic vascular resistance rather than systemic cardiac output may not offer any benefit in systemic oxygen delivery [27–29].

Venous saturation can be measured directly by venous blood gases, but this is invasive and is associated with cost. Additionally, this can only be done intermittently. Thus, noninvasive means of estimation have been tested. Regional near infrared spectroscopy has been demonstrated to be associated with underlying regional venous saturations and thus has also been demonstrated to be associated with similar morbidity as with regional venous saturations [30]. The IDO2-50% strives to similarly reflect the trend in the mixed venous saturation in a continuous fashion using real-time hemodynamic and laboratory data.

Limited data have been published to date regarding the clinical implications of the IDO2 index. Studies to date demonstrated that the IDO2 index can help identify adverse events in children with sepsis, may assist with evaluating extubation readiness in children after cardiac surgery, may aid in early identification of children at risk for cardiorespiratory arrest, may aid in weaning vasoactive medications in children after cardiac surgery [31–35]. It should be noted that while these studies have demonstrated utility of the IDO2 index one study failed to find that the IDO2 index had prognostic utility [36].

While additive to the literature, these data are not without their limitations. First, this is a single center study and center specific practices may be mediating some of the data. However, as the aim was to correlate two measured values this seems to be of less importance. Second, a central venous saturation was utilized and not a mixed venous saturation although the IDO2 index was designed to estimate the probability of the mixed venous saturation being a certain value. Central venous saturations, both SVC and IVC saturations should trend similarly with the mixed venous saturation thus it is still reasonable to understand the correlation between the two, particularly central venous saturations are what are more commonly available in routine clinical practice. The SVC and IVC saturations should have values within 10 of each other meaning that the difference of to the mixed venous saturation should be even less than that. Thus, the absolute difference of to the actual mixed venous saturation should not be that great. If anything, this means that the current data offer an underestimate of the correlation.

Future studies quantifying the correlation of the IDO2 index to the SVC saturation and the mixed venous saturation will be helpful. Additional studies characterizing the association of the IDO2 index to clinical outcomes will also be helpful.

The IDO2 index has moderate correlation with IVC saturation. It has good sensitive and negative predictive value. Cerebral near infrared spectroscopy does appear to correlate better with the underlying venous saturation than the IDO2 index.

Acknowledgements

None

Funding declaration

This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data Transparency

All data and materials, as well as software application, support our published claims and comply with field standards.

Compliance with ethical standard

Conflict of Interest: The authors declare that they have no conflict of interest.

Statement of human rights: The Study have been approved by the appropriate institutional ethics committee and have been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Author Contributions

Rohit S. Loomba, Saul Flores and Enrique G. Villarreal contributed to the study conception and design. Material preparation, data collection and analysis were performed by Juan S. Farias, and Alex Constas. The first draft of the manuscript was written by Rohit S. Loomba and Enrique G. Villarreal. Saul Flores and Juan S. Farias commented on previous versions of the manuscript. All authors read and approved the final manuscript. Reviewing and editing was done by Enrique G. Villarreal, Rohit S. Loomba and Alex Constas.

Conflict of Interests:

The authors declare that they have no conflict of interest.

Statement of human rights:

The Study have been approved by the appropriate institutional ethics committee and have been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Availability of Data and Material:

All data and materials, as well as software application, support our published claims and comply with field standards.

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No competing interests reported.

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You are reading this latest preprint version

The Inadequate Oxygen Delivery Index and its Correlation with Venous Saturation in the Pediatric Cardiac Intensive Care Unit

Status:

Journal Publication

Version 1

Abstract

Background

Methods

Results

Conclusion

Introduction

Methods

Study design

Variables of interest

Patient inclusion

Statistical analyses

Results

Cohort information

Correlation of the IDO2-50% and the IVC saturation

Correlation of the IDO2-50% and other hemodynamic parameters

Correlation of the IVC saturation with near infrared spectroscopy

Receiver operator curve analysis

Regression analysis of the IDO2-50%

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Journal Publication

Version 1