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The Ties That Bind: Evaluation of a Patient-worn Pulse Oximeter Compared to Traditional Pulse Oximetry on Loss of Signal Integrity in Pediatric Patients
Sponsor study identifier
observational
36
1 country
1
Study Start
July 26, 2017
Actual (reported)Primary Completion
November 1, 2017
Actual (reported)Study Completion
November 1, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2017
Actual (reported)June 15, 2017
Actual (reported)July 26, 2017
Actual (reported)November 1, 2017
Actual (reported)November 1, 2017
Actual (reported)instances of alarm state corresponding to loss of signal integrity
Loss of signal integrity is defined as complete inability to pick up the patient signal or a change in the pulse oximetry saturation value by 4%.
20 minutes
12 subjects in the age range of 1-6 years old.
12 subjects in the age range of 6-10 years old.
12 subjects in the age range of 11-17 years old.
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 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.
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Lawless ST. Crying wolf: false alarms in a pediatric intensive care unit. Crit Care Med. 1994 Jun;22(6):981-5.
Seixas DM, Seixas DM, Pereira MC, Moreira MM, Paschoal IA. Oxygen desaturation in healthy subjects undergoing the incremental shuttle walk test. J Bras Pneumol. 2013 Jun-Aug;39(4):440-6. doi: 10.1590/S1806-37132013000400007.
Pamela C Petersen, M.D.
Medical College of Wisconsin Affiliated Hospitals, Inc.
Sheila Hanson, M.D.
Medical College of Wisconsin Affiliated Hospitals, Inc.
36 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2017
First Posted
June 15, 2017
Study Start
July 26, 2017
Actual (reported)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%.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 1, 2017
Actual (reported)Study Completion
November 1, 2017
Actual (reported)Last Updated
November 24, 2017
Record last verified: 2017-11
At the end of the study, Masimo, who makes both of the pulse oximeters, will be able to see de-identified information. They will not be allowed to see "Protected Health Information" (PHI). IPD that will be shared includes Subject Number, Age, Race, Gender, Probe Location (dominant vs. nondominant hand), Activity (Likert score), Start time of activity, Stop time of activity, Radius 7 Probe location, Radical 7 Probe location, Instance of alarm state Radius 7, Duration of alarm state Radius 7, Loss of signal integrity Radius 7-Change in pulse ox saturation of 4% or more, Loss of signal integrity Radius 7-no signal, Instance of alarm state Radical 7, Duration of alarm state Radical 7, Loss of signal integrity Radical 7-Change in pulse ox saturation of 4% or more, and Loss of signal integrity Radical 7-no signal. This de-identified data with no PHI will be shared via USB stick or e-mail electronically.
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Source: ClinicalTrials.gov.
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