2006 OPEN FORUM Abstracts
COMPARISON OF TWO NEWER-GENERATION PULSE OXIMETERS IN THE NEONATAL INTENSIVE CARE UNIT(NICU).
Michael Sautel BS RRT Children's Memorial
Hospital, Chicago, Illinois.
Background: Pulse oximeters used in the NICU
setting must provide reliable data during various conditions of signal
interference, including light, motion, and reduced perfusion. Improved system
designs in newer generation pulse oximeters are intended to allow proper
operation under the conditions commonly encountered in the NICU environment. This study aims to assess differences in
device posting in newer oximeter systems.
Methods: Following informed consent,
10 infants between 27-40 weeks gestational age and < 1 month old in
chronological age were recruited from the NICU.
A Nellcor® OxiMax® N-600 T Pulse
Oximeter, version 1.1.2.0 (Nell) and Masimo® SET® Radical® pulse oximeter, v4 (Mas) using MAX-N
and LNOP® Neo sensors, respectively.
Sensors were placed on either foot and optically shielded to prevent
cross-talk. Each subject study was targeted for 4 hrs with 2 hr sensor
rotation. Pulse oximeter data was captured via serial interface connection to a
lap-top computer and sampling of 1Hz. McNemar's test analysis used to compare ability of oximetry systems to record
saturation (Sp02) and pulse rate (PR). Dropout rate was defined as the
percentage of total monitoring time where data is not detected the pulse
oximeter.
Results:
GA
(wks) 36.5 ± 2.5 Study
Age (d)11.7 ± 5.19 Resting ECG
HR (bpm) 140 ±10.6 Birth/Study wt (kg) 3 ± .616 / 3.11 ±
0.549.
Recording
time available for analysis was 39.2 hours. Sp02 mean
difference ± SE (Mas - Nell) was 1.46 ± 0.36, which was statistically significant
(p<0.0032). PR mean difference (Mas -
Nell) was -1.21 ± 0.74, which was not statistically significant, p=0.137. Both PR and Sp02 differences were adjusted
for repeated observations on the same patient using a mixed model.
| PR N % (sec) | Sp02 N % (sec) | |
| Mas and Nell both dropped out | 15 0.01 | 13 0.01 |
| Mas only dropped out | 947 0.67 | 904 0.64 |
| Nell only dropped out | 610 0.43 | 464 0.33 |
| Neither dropped out | 139,645 98.89 | 139,836 99.02 |
Overall
Mas drop-out rate was statistically higher than Nell p<0.0001 (McNemar's
Test). Adjusting for correlations between observations on same patient using
generalized linear modeling, p<0.0001. While SpO2 and PR dropouts with both
monitors was less than 1% of the recorded time, Mas SpO2 was 1.94 times more
likely to drop out than Nell (95% CI = 1.74 - 2.17), and Mas PR was 1.55 times
more likely to dropout than Nell (95% CI = 1.40 -1.72).
Conclusions:
Although
the OxiMax N-600 had fewer dropouts compared to the Radical, both oximeters
posted values >99% of the total monitoring time. Both the Nellcor OxiMax N-600 and Masimo SET
Radical, as new generation oximeters, performed similarly with regard to
overall drop-out rate and both are judged to be clinically equivalent in
providing reliable pulse rate and saturation monitoring of babies in the NICU.
This
study was financially supported and the equipment supplied by Nellcor/Tyco
Healthcare.