Abstract
The aim was to determine the precision of a noninvasive near-infrared spectroscopy (NIRS)-based tissue oximeter (OxyPrem v1.3). Using a linear mixed-effects model, we quantified the variability for cerebral tissue oxygenation (StO2) measurements in 35 preterm neonates to be 2.64%, a value that meets the often-articulated clinicians' demand for a precise tissue oxygenation measurement. We showed that the variability of StO2 values measured was dominated by spontaneous systemic hemodynamic fluctuations during the measurement, meaning that precision of the instrument was actually even better. Based on simultaneous and continuous measurements of peripheral arterial oxygenation and cerebral StO2 with a second sensor, we were able to determine and quantify the physiological instability precisely. We presented different methods and analyses aiming at reducing this systematic physiological error of in vivo precision assessments. Using these methods, we estimated the precision of the OxyPrem tissue oximeter to be ≤ 1.85 % . With our study, we deliver relevant information to establish highly precise cerebral oxygenation measurements with NIRS-based oximetry, facilitating the further development toward a substantially improved diagnosis and treatment of patients with respect to brain oxygenation.
Highlights
Infants born preterm are vulnerable to hypoxic and ischemic cerebral insults that can lead to long-term morbidity.[1]
A typical time series of one patient (ID 12) of the frontotemporal lobe (FTL) and occipital lobe (OL) StO2 (ROI1þ2) and of SpO2 is shown in Fig. 2, which shows that all signals are strongly affected by spontaneous fluctuations
The results show that our new in-house developed near-infrared spectroscopy (NIRS)-based oximeter device OxyPrem with a precision of 2.64% achieves the requirements for clinical practice, which are requested to be
Summary
Infants born preterm are vulnerable to hypoxic and ischemic cerebral insults that can lead to long-term morbidity.[1] Diagnostic methods to early detect these conditions and to prevent lesions are urgently needed. Optical methods such as near-infrared spectroscopy (NIRS) have the potential to fulfill this need by assessing cerebral oxygenation and blood perfusion (hemodynamics) noninvasively, especially by being able to measure the tissue oxygenation (StO2) as an absolute parameter.[2,3] The measurement of cerebral StO2 may be useful for detecting situations where the oxygenation of the brain is impaired; the hope is that by properly adjusting the cerebral oxygenation, brain lesions will be prevented. Recent studies showed that a higher precision in neonates of 2.0% (term) to 4.2% (preterm) can be achieved by excluding inhomogeneous tissue for the OxiplexTS (ISS, Champaign, Illinois).[5]
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