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Pulse oximetry to screen for congenital heart disease in newborns

Clinical Question:
Is pulse oximetry effective in screening newborns for congenital heart disease?

Bottom Line:
Although pulse oximetry is easy, inexpensive, and noninvasive, it is only 44% sensitive in detecting congenital heart disease, and it will take a randomized trial to determine whether pulse oximetry actually improves outcomes. (LOE = 2b)

Ewer AK, Middleton LJ, Furmston AT, et al, for the PulseOx Study Group. Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): a test accuracy study. Lancet 2011;378(9793):785-794.  [PMID:21820732]

Study Design:
Cohort (prospective)


Inpatient (any location) with outpatient follow-up

This study evaluated more than 20,000 apparently healthy term newborns with pulse oximetry. The researchers applied the pulse oximeter to the palm of the right hand and to the sole of the right foot of each newborn. They defined an abnormal test result as oxygen saturation of less than 95% or a more than 2% difference between the palm and sole readings (when the oxygen saturation was more than 95%). They then performed echocardiography on infants with abnormal results and followed up for 1 year. Information from infants who did not receive echocardiography was obtained through congenital anomalies registers and mortality registers to identify all cases of congenital heart defects that needed intervention within 1 year. Although a more rigorous design would have all infants undergo echocardiography, the clinical follow-up seems to be valid as long as sudden deaths are attributed to congenital heart disease. Differential application of a gold standard tends to overestimate the test sensitivity. Among the 195 infants with abnormal oximetry results, 32 had congenital heart defects (18 critical, 8 serious, 6 significant). Among the remaining infants with normal pulse oximetry results, 41 had congenital heart defects (6 critical, 21 serious, and 14 significant). This works out to be approximately 44% sensitive and 99% specific. The authors "played" a bit more to see how well oximetry performs for detecting major or critical defects and report sensitivity/specificity as 50%/99.9% and 36%/99.9%, respectively. Remember, the most desirable quality is to have a very sensitive test so that when the result is negative it can effectively "rule out" disease. In this case, the overall rate of congenital defects is so low, even an inaccurate test looks pretty good if you report the predictive value of a negative test.


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