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

NCT03187665 | Completed FDA Device

• 1 other identifier: 953341-1
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric; Pulse Oximeter; Wireless; Motion; False Alarm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

1-6 years

12 subjects in the age range of 1-6 years old.

Device: Radical 7; Device: Radius 7

6-10 years

12 subjects in the age range of 6-10 years old.

Device: Radical 7; Device: Radius 7

11-17 years

12 subjects in the age range of 11-17 years old.

Device: Radical 7; Device: Radius 7

Interventions

Radical 7 DEVICE

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%.

Also known as: Masimo Radical 7 Pulse Oximeter

1-6 years; 11-17 years; 6-10 years

Radius 7 DEVICE

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%.

Also known as: Masimo Radius 7 Pulse Oximeter

1-6 years; 11-17 years; 6-10 years

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pamela Petersen: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• Lawless ST. Crying wolf: false alarms in a pediatric intensive care unit. Crit Care Med. 1994 Jun;22(6):981-5.

  PMID: 8205831 BACKGROUND

• 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.

  PMID: 24068265 BACKGROUND

Study Officials

• Pamela C Petersen, M.D.

  Medical College of Wisconsin Affiliated Hospitals, Inc.

  PRINCIPAL INVESTIGATOR

• Sheila Hanson, M.D.

  Medical College of Wisconsin Affiliated Hospitals, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Critical Care Fellow

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: July 26, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)