Alarms Due to Loss of Signal Integrity in Partially Wireless Versus Traditional Pulse Oximetry in Pediatric Patients

PURPOSE OF THE STUDY This study will evaluate the loss of signal integrity secondary to
motion in pediatric subjects being monitored with a newer, partially wireless pulse oximeter
(the Radius 7) which eliminates the cable connecting the subject to a wall unit by instead
connecting to a small device worn on the subject's arm or leg. The Radius 7 will be compared
to the traditional wall-connected pulse oximeter currently used at Children's Hospital of
Wisconsin (CHW) which requires a cable connecting to a wall unit (the Radical 7).

HYPOTHESIS Continuously monitoring pulse oximetry with a partially wireless monitor without
physical connection to a wall unit will decrease episodes of loss of signal integrity
generated by motion artifact in healthy pediatric subjects completing age appropriate
activities.

BACKGROUND, SIGNIFICANCE, AND RATIONALE Pulse oximetry is used in both inpatient and
outpatient environments to measure the oxygen saturation in a person's blood and the pulse,
or heart rate. Pulse oximeters use a painless Band-Aid-like probe that attaches to a
fingertip, toe, hand or foot and shines a light through the skin. The monitor then determines
how much oxygen is in the blood and the pulse rate based on the way the light passes through
the skin. The probe is connected to the monitor by a cable of varying lengths. Movement can
cause incorrect pulse oximeter measurements.

Continuous pulse oximetry is considered a standard of care in pediatric intensive care units;
however pediatric patients have a high incidence of false alarms in part due to motion
artifact. These false alarms contribute to the 94% false alarm incidence in pediatric ICU
patients. (Lawless) Motion artifact is potentially exacerbated by the long cables connecting
the patients to the continuous monitors. Currently the FDA has not approved any completely
cable-free pulse oximeters for continuous use; however Masimo has produced a device (the
Radius 7) that overcomes the previously required cable connection to a wall unit via wireless
transmission from a patient-worn continuous monitor. (Masimo) There are currently no studies
looking at this patient worn monitor in relation to the motion artifacts that frequently
cause false alarms in pediatric patients.

The Joint Commission has listed alarm fatigue as a top patient safety concern and as of
January 1, 2016 has required hospitals to establish policies and procedures for managing
alarm fatigue. Reduction in false alarms is necessary to reduce alarm fatigue. This pilot
study will use clinical data to measure the effect of eliminating this cable-to-wall
connection on motion artifact. Additionally, early mobility in critically ill patients has
been shown to improve outcomes. Freeing patients from one of the cables currently tying them
to the room may decrease the false alarms from motion artifact while simultaneously improving
mobility, therefore improving patient outcomes and safety.

DESIGN AND METHODS Subjects: Healthy pediatric subjects ranging from 6 months to 17 years of
age. Pediatric subjects will be recruited via fliers placed in pediatric critical care areas,
in the Translational Research Control Unit (TRU) and on the MCW research bulletin board
outside the MCW office of research. Subjects may include those responding to the fliers
directly as well as the healthy siblings of patients being evaluated or treated in the
Children's Hospital of Wisconsin Emergency Room (EDTC), Clinics or Hospital.

Setting: The Children's Hospital of Wisconsin (CHW): primarily in the TRU designed to mimic a
CHW outpatient clinic room; and also including available sites near the EDTC or clinic to
facilitate making testing more convenient for the subject's family if the subject is a
healthy sibling of a patient being evaluated in the EDTC or clinic.

Procedures:

While being continuously monitored on the current equipment used by CHW (the wall-connected
Radical 7) and the partially wireless Radius 7 pulse oximeter, subjects will be asked to
complete age appropriate activities as developed by CHW physical therapists, for
approximately twenty minutes. These activities include common childhood activities such as
kicking a ball or drawing with crayons. If a subject declines to participate in an activity,
an alternate will be suggested. The investigators will analyze the pulse oximetry data for
instances of alarm state corresponding to loss of signal integrity as defined by complete
inability to pick up the subject signal or a change in the pulse oximetry saturation value by
4%. (Seixas, Seixas and Pereira)

Endpoints: Enrollment of and data acquisition on 48 pediatric subjects: 12 in each of the
following developmental age groups: 6 month-1year, 1-6 years, 6-10 years, and 11-17 years.

Data analysis:

All data will be collected in a de-identified manner in which subjects will be given a study
case number and all data will be collected under that case number.

The number of episodes of loss of signal integrity leading to an alarm state generated by the
wall-connected Radical 7 unit compared to the partially wireless Radius 7 unit during
completion of the developmentally appropriate activities will be compared. Analysis will be
performed by the Quantitative Health Sciences department at MCW and a 20% reduction in
episodes of loss of signal integrity will be considered clinically significant.

TOTAL NUMBER OF HUMAN RESEARCH PARTICIPANTS PROPOSED FOR THIS STUDY. 48 pediatric subjects:
12 in each of the following developmental age groups: 6 months-1year, 1-6 years, 6-10 years,
and 11-17 years. This number of participants will provide representative data for a pilot
study investigating the most common age groups seen in the pediatric ICU in order to identify
the age groups most likely to benefit from further study.

Inclusion Criteria:

- Healthy subjects between the ages of 6 months and 17 years at the time of data
acquisition.

Exclusion Criteria:

- Subjects will be excluded if they have any pre-existing cardiac or pulmonary chronic
medical diagnoses as determined by asking the subject's guardian.