Alarms Due to Loss of Signal Integrity in Partially Wireless Versus Traditional Pulse Oximetry in Pediatric Patients
Condition: Healthy
Study type: Observational

Summary: 
      This research study will help the investigators to learn more about a device used when
      children are sick called a pulse oximeter. The pulse oximeter measures how much oxygen is
      inside a child's blood without taking blood from the child. It is non-invasive meaning it
      does not enter the body. The device has a cable attached to it. At the end of the cable is a
      wrap that looks like a Band-Aid with a red light on it. This wrap is placed around a finger
      or toe. The red light gives the investigators a reading of how much oxygen is in the child's
      blood and the child's heart rate. Having a pulse oximeter connected to a child is painless.
      This device is used in many places. Besides hospitals, it is used in doctors' offices and in
      fitness centers.

      This study will help the investigators learn more about whether a partially wireless, more
      portable pulse oximeter that connects to a small device worn on the child's arm or leg will
      give the investigators a more reliable signal/reading while letting children move more
      easily. The investigators will compare this device with the traditional wall-connected unit.
      Movement of the cable or a child moving may give a false oxygen reading. The investigators
      will ask the child to do activities that create movement and will look at the readings when
      the child moves. The investigators think the partially wireless pulse oximeter will be more
      reliable during movement than the traditional wall-connected unit.

      Subjects will have two continuous pulse oximeter probes placed on them. These soft probes
      will go on a finger, toe, foot or hand and will be attached to two different pulse oximeter
      monitors. The child will then be asked to do common childhood activities based on their age
      for about 20 minutes. These activities will be play activities the child already does such as
      grabbing a toy, drawing with crayons or kicking a ball. Continuous pulse oximetry data will
      be recorded during the testing and will be stored in a way that it cannot be linked to the
      subject after the testing is complete.
    

Detailed description: 
      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.
    

Intervention name(s): Radical 7; Radius 7
Intervention type(s): Device; Device
Intervention description(s): The Radical 7 is the traditional wall-connected pulse oximeter currently used at Children's Hospital of Wisconsin (CHW) which requires a 12 foot cable connecting the patient to a wall unit. While being continuously monitored with the Radical 7 pulse oximeter, subjects will be asked to complete age appropriate activities. The pulse oximetry data will be analyzed 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%.; The Radius 7 is a newer, partially wireless pulse oximeter which eliminates the cable connecting the patient to a wall unit by instead connecting to a small device worn on the patient's arm or leg. The small device then sends the continuous pulse oximeter data wirelessly to the central monitoring station. While being continuously monitored with the Radius 7 pulse oximeter, subjects will be asked to complete age appropriate activities. The pulse oximetry data will be analyzed 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%.
Other intervention name(s): Masimo Radical 7 Pulse Oximeter; Masimo Radius 7 Pulse Oximeter
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects will be a sampling from the communities served by the Children's Hospital of
        Wisconsin. Pediatric subjects will be recruited via fliers placed in pediatric critical
        care areas, in the Translational Research Control Unit (TRU) and on the Medical College of
        Wisconsin (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.
      
Keywords: Pediatric; Pulse Oximeter; Wireless; Motion; False Alarm