2020
KHOURY CLINICAL SUMMARY
Monitoring oxygen saturation and heart rate during neonatal transition. Comparison
between two different pulse oximeters and electrocardiography
Khoury, R., Klinger, G., Shir, Y., Osovsky, M., & Bromiker, R. Journal of Perinatology, 2020 Nov;1-6.
STUDY OBJECTIVE:
To compare the efficacy and reliability of two pulse-oximeters
(POx) (Masimo Radical-7 and Nellcor™ Oximax Bedside) and
evaluate the feasibility of routine ECG monitoring during
delivery room transition
KEY TAKEAWAYS:
Nellcor time to stable oximeter signal was significantly faster than Masimo, by 12 seconds on average
Nellcor pulse rate (PR) readings were strongly correlated with ECG heart rate
Nellcor recorded no instances of false bradycardia (heart rate <100 beats per minute (bpm)). Masimo recorded
false bradycardia in 18 of 55 (35%) newborns, with 16 of 55 (31%) newborns having a difference in heart rate
that was over 40bpm lower than ECG heart rate
BACKGROUND:
Pulse oximetry and ECG monitoring are recommended by the American Academy of Pediatrics (AAP)
and the American Heart Association (AHA) during neonatal resuscitation
Continuous monitoring of blood oxygen saturation (SpO2) via pulse oximetry helps to avoid adverse
events associated with high or low oxygen concentration
Study objective: compare the efficacy and reliability of Masimo Radical-7 and Nellcor™ Oximax Bedside Monitor,
and evaluate the feasibility of routine ECG monitoring during delivery room transition
METHODS:
Prospective, observational study in delivery room at a tertiary hospital from June, 2017 – February, 2019
Sixty full-term and pre-term newborns delivered via C-section
During resuscitation/stabilization period, both oximeters were simultaneously connected to each foot
(side randomized)
Masimo Radical-7 monitor and M-LNCS sensors (Masimo set to MAX sens and fastest average time)
Nellcor Oximax Bedside SpO2 monitor and Neonatal-Adult (MAXN) SpO2 sensors (Nellcor set to Fast mode)
ECG (Philips Efficia CM120) heart rate was simultaneously recorded
All sensors were first applied to the newborn, before connecting the cable to the oximeter. 1, 2
The primary outcome was time to stable oximeter signal
Defined as “simultaneous saturation and heart rate measurement for at least three beats that was appropriate
for the newborn’s clinical appearance”
Infants with known major congenital anomalies or limb anomalies that might interfere with saturation reading
were excluded
2020
KHOURY CLINICAL SUMMARY
RESULTS:
Sixty newborns were enrolled in the study
Data available for 55 patients
Average gestational age was 36 weeks
Nellcor obtained a stable signal in 100% of patients, whereas Masimo obtained a stable signal in 92% of patients
Nellcor obtained a stable signal significantly faster than Masimo (average time: 15 seconds v. 27 seconds,
respectively, p<0.001)
Nellcor PR readings were strongly correlated with ECG readings (r=0.894) and, on average, there was no statistical
difference in heart rate between Nellcor and ECG (158bpm v 163bpm, p>0.05). Masimo heart rate readings, on
average, were significantly lower than ECG readings (156bpm v 162bpm, p=0.001)
Nellcor recorded no instances of false bradycardia. In 35% of cases, Masimo recorded false bradycardia
(heart rate less than 100 bpm)
False bradycardia may result in the use of unnecessary, potentially harmful, resuscitation maneuvers
Detachment of ECG leads was reported in 16% of patients
Potential difficulty placing leads and obtaining stable ECG signal in neonates
Table 1: Comparison of Nellcor and Masimo Pulse Oximeters in Neonates During Transition Period – Study Results
Nellcor Oximax Pulse Oximetry Masimo Radical-7
Stable signal obtained (% of patients) 100% 92%
Average time to stable signal 15 seconds 27 seconds
Heart rate compared to ECG (correlation coefficient) Strongly correlated (r=0.894) Weakly correlated (r=0.235)
Mismatch ≥ 40bpm compared to ECG (% of patients) 0% 31%
False bradycardia (% of patients) 0% 35%
NOTES ON INDUSTRY INVOLVEMENT:
Neither Medtronic nor Masimo had a role in study design, execution, interpretation or writing
Masimo provided pulse-oximeter and sensors, and requested to see data before publication
Medtronic provided Nellcor sensors
1 Saraswat, A., Simionato, L., Dawson, J. A., Thio, M., Kamlin, C. O. F., Owen, L., ... & Davis, P. G. (2012). Determining the best method of
Nellcor pulse oximeter sensor application in neonates. Acta Paediatrica, 101(5), 484-487.
2 O’Donnell, C. P. F., Kamlin, C. O. F., Davis, P. G., & Morley, C. J. (2005). Obtaining pulse oximetry data in neonates: a randomised crossover
study of sensor application techniques. Archives of Disease in Childhood-Fetal and Neonatal Edition, 90(1), F84-F85.
The Nellcor™ pulse oximetry monitoring system should not be used as the sole basis
for diagnosis or therapy and is intended only as an adjunct in patient assessment.
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