Evaluation of Pulse Oximetry Sensors in Neonates

A common method for assessing the respiratory status of hospitalized children is the use of
pulse oximetry. This noninvasive device typically is placed on a finger, foot/palm of a
child. Red and infrared light is shined through the tissue under the sensor and the
information is sent back to a monitor for calculation of oxygen saturation. Use of this
noninvasive method provides continuous information on the oxygenation status of patients and
has greatly reduced the number of arterial blood samples required for patient care.

While the advantages of noninvasive pulse oximetry are significant, there are a number of
factors which can negatively impact the performance of the device. Patient movement and
sensor adherence to the skin have been some of the challenges to optimal device performance.
While much of the clinical research on pulse oximetry sensors over the years has evaluated
device accuracy and reliability, limited data is available on sensor longevity under
conditions typical of clinical use. A particular challenge with neonatal pulse oximetry
monitoring is insuring proper sensor adherence within the warm, moist environment of
incubators used in neonatal care. Furthermore, limited data are available on the impact of
sensor adherence on skin integrity in premature infants who are at high risk for skin
breakdown.

Objectives. The purpose of this study is to evaluate sensor longevity and impact on skin
integrity in neonatal patients with two different models of pulse oximetry sensors.

Research Method. A sample of 32 premature infants will be recruited to participate in this
study in which an adhesive sensor and a nonadhesive sensor are compared. Both sensors will
be simultaneously tested in each subject, for a period of 14 days, with one sensor on the
right foot and the other sensor on the left foot. Data will be collected on sensor
longevity, skin integrity at the sensor site, reason for sensor replacement and ease of use
rating by the clinician. Data will be summarized using descriptive statistics.

Inclusion Criteria:

- Gestational age < 34 weeks

- Weight < 3.0 kg

- Postnatal age < 2 weeks

- Anticipated pulse oximetry monitoring for at least 14 days

Exclusion Criteria:

- Presence of any skin irritation or breakdown on either foot

- Foot impediments which would preclude proper placement of the test sensors

- Known allergies to adhesive materials