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

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.

Conditions

• Healthy

Interventions

DEVICE

Radical 7

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%.

DEVICE

Radius 7

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%.

Sponsors & Collaborators

• Pamela Petersen

  lead OTHER

Principal Investigators

• Pamela C Petersen, M.D. · Medical College of Wisconsin Affiliated Hospitals, Inc.

• Sheila Hanson, M.D. · Medical College of Wisconsin Affiliated Hospitals, Inc.

Eligibility

Min Age

6 Months

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-07-26

Primary Completion

2017-11-01

Completion

2017-11-01

FDA Device

Yes

Countries

• United States

Study Locations