SpO2 Accuracy In Vivo Testing for Neonates & Infants

Pulse Oximetry Clinical Trial

Official title:

SpO2 Accuracy In Vivo Testing for Neonates & Infants - Convenience Arterial Samples Compared to CO-Oximetry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03843489
• Other study ID #: PR2018-296
• Status: Terminated
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: September 20, 2021

Study information

• Verified date: November 2021
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

FDA Guidance for pulse oximeters (March 4, 2013), section 4.1.2, In vivo testing for SpO2 accuracy for neonates, calls for the devices to be first tested in adults during hypoxia tests with arterial samples compared to measured oxygen saturation. This has been previously completed on the devices that will be tested in this protocol. In order to verify safe clinical performance in the neonate, the FDA then requires testing using neonatal arterial samples that are collected in the normal course of care; which is the primary purpose of this protocol. As a secondary purpose the data will be utilized to evaluate the impact of calculated oxygen saturation versus measured oxygen saturation and related issues.

Neonates/infants who will have an arterial line or sheath placed in the normal course of care will be included in this study. The pulse oximeter sensor must be placed on the Neonates/infant's foot or hand. Neonates who either have repaired PDA but are having the placement of the sensor on the foot (which will be arterial blood only) will be allowed as long as other inclusion/exclusion criteria are met.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pulse Oximetry

Intervention

Device:
• MEDLINE RENEWAL PULSE OXIMETRY SENSORS
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.
• Reference CO-oximetry sensor
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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Medline Industries	Clinimark, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Calculated oxygen saturation versus measured oxygen saturation	The arterial sample will always be measured in the reference co-oximeter. The sample may also be measured in the currently used AVOX 1000E.	4 hours