Healthy Clinical Trial
Official title:
The Ties That Bind: Evaluation of a Patient-worn Pulse Oximeter Compared to Traditional Pulse Oximetry on Loss of Signal Integrity in Pediatric Patients
Verified date | November 2017 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 1, 2017 |
Est. primary completion date | November 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 17 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Pamela Petersen |
United States,
Lawless ST. Crying wolf: false alarms in a pediatric intensive care unit. Crit Care Med. 1994 Jun;22(6):981-5. — View Citation
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. English, Portuguese. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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