NCT03843489

Brief Summary

The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of various pulse oximetry systems and sensors (new designs and/or reprocessed) during non-motion conditions as compared to arterial blood samples, drawn in the normal course of patient care, assessed by CO-Oximetry in neonates and infants. The primary end goal is to provide supporting documentation for the SpO2 accuracy of these pulse oximetry systems. The secondary end goal is to provide data for evaluation of clinical impact of measured to calculated SaO2 and related issues.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

March 19, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

2.5 years

First QC Date

February 12, 2019

Last Update Submit

August 27, 2024

Conditions

Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

  • Validation of SpO2 accuracy of pulse oximetry sensors

    To validate SpO2 accuracy performance of Sponsor sensors by an Accuracy Root Mean Square (Arms) value. Reference CO-Oximetry will be used as the basis for comparison for the investigational device SpO2 readings.

    4 hours

Secondary Outcomes (1)

  • Calculated oxygen saturation versus measured oxygen saturation

    4 hours

Study Arms (2)

MEDLINE RENEWAL PULSE OXIMETRY SENSORS

EXPERIMENTAL

Reference sensors from the reprocessed oximeter device will be placed on each subject to evaluate the SpO2 accuracy and performance.

Device: MEDLINE RENEWAL PULSE OXIMETRY SENSORS

Reference CO-oximetry sensor

SHAM COMPARATOR

A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.

Device: Reference CO-oximetry sensor

Interventions

MEDLINE RENEWAL PULSE OXIMETRY SENSORSDEVICE

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.

MEDLINE RENEWAL PULSE OXIMETRY SENSORS
Reference CO-oximetry sensorDEVICE

A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.

Reference CO-oximetry sensor

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Neonates/Infants up to 28 days old
  • Neonates/Infants less than 5kg.
  • And one of the following:
  • Without PDA With a PDA with R-L shunting that will be repaired before arterial samples are taken

You may not qualify if:

  • Physical malformation of feet or toes or other sensor sites which would limit the ability to place the sensors for the study.
  • Neonates/Infants older than 28 days old.
  • Neonates/Infants outside the weight range for the sensor (Greater than 5kg.)
  • Neonates/Infants with unrepaired PDA. with PDA with R-L shunting
  • Subjects who are undergoing bilirubin light therapy while samples are being obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

  • Robin Deterding, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Hospital staff will place the pulse oximeter sensor(s) on one or both hand or feet of the neonate/infant and start the pulse oximeter data collection computer to record continuously. Each time an arterial CO-Oximeter sample is collected the data collection file will be marked by pressing the file marker key on the data collection computer. Information from each arterial CO-Oximeter sample will be written on the CRF. The arterial sample will always be measured in the reference co-oximeter. The sample may also be measured in the currently used AVOX 1000E. This study will only use arterial blood samples that are taken in the normal course of care; the sample size of the blood draw will not be altered for this study (sample size will not be increased from the normal course of care for any portion of this study).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 18, 2019

Study Start

March 19, 2019

Primary Completion

September 20, 2021

Study Completion

September 20, 2021

Last Updated

August 28, 2024

Record last verified: 2024-08

Locations

US(1)