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

November 21, 2017 updated by: Pamela Petersen

The Ties That Bind: Evaluation of a Patient-worn Pulse Oximeter Compared to Traditional Pulse Oximetry on Loss of Signal Integrity in Pediatric Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1-6 years
12 subjects in the age range of 1-6 years old.
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%.
Other Names:
  • Masimo Radical 7 Pulse Oximeter
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%.
Other Names:
  • Masimo Radius 7 Pulse Oximeter
6-10 years
12 subjects in the age range of 6-10 years old.
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%.
Other Names:
  • Masimo Radical 7 Pulse Oximeter
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%.
Other Names:
  • Masimo Radius 7 Pulse Oximeter
11-17 years
12 subjects in the age range of 11-17 years old.
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%.
Other Names:
  • Masimo Radical 7 Pulse Oximeter
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%.
Other Names:
  • Masimo Radius 7 Pulse Oximeter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
instances of alarm state corresponding to loss of signal integrity
Time Frame: 20 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamela Petersen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 953341-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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