Neonatal Pulse Oximetry Sensor Study

Premature Birth Clinical Trial

Official title:

Accuracy and Precision of Peripheral Capillary Oxygen Saturation of Reprocessed Pulse Oximetry Sensors Compared to Oxygen Saturation in Arterial Blood Samples Assessed by CO-oximetry in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250102
• Other study ID #: MED-2020-DIV65-001
• Status: Completed
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: October 10, 2023

Study information

• Verified date: March 2023
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.

Description:

Pulse oximetry helps in measuring peripheral capillary oxygen saturation (SpO2) continuously and non-invasively, and provides an indirect measurement of arterial oxygenation (SaO2) based on the red and infrared light-absorption characteristics of oxygenated and deoxygenated hemoglobin. Uses of pulse oximetry include detection of hypoxia, avoidance of hyperoxia, titration of fractional inspired oxygen, and enabling weaning from mechanical ventilation. Arterial blood gas (ABG) analysis, such as by the use of CO-oximeter, provides a direct measurement of SaO2. However, ABG analysis requires time, expense, and arterial access. Therefore, this study aims to validate the SpO2 accuracy of pulse oximetry sensors (manufactured by Nellcor and Masimo, and reprocessed by Medline Industries, LP) in neonates as compared to ABG measurements as part of their clinical standard of care (SOC), as assessed by CO-oximetry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

Inclusion Criteria:

• Subjects who are postnatal 28 days or younger (neonates)

• Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC

• Subjects who weigh less than 5 Kg (weight range for thesensors)

Exclusion Criteria:

• Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement

• Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study

• Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study

• Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)

Related Conditions & MeSH terms

• Premature Birth

Intervention

Device:
• Pulse oximeter sensors
Pulse oximeter reading will be compared to CO-oximeter reading.

Locations

Country	Name	City	State
United States	Eastern Carolina University	Greenville	North Carolina
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ascha M, Bhattacharyya A, Ramos JA, Tonelli AR. Pulse Oximetry and Arterial Oxygen Saturation during Cardiopulmonary Exercise Testing. Med Sci Sports Exerc. 2018 Oct;50(10):1992-1997. doi: 10.1249/MSS.0000000000001658. — View Citation

Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. doi: 10.1080/10543400701329422. — View Citation

Dawson JA, Davis PG, O'Donnell CP, Kamlin CO, Morley CJ. Pulse oximetry for monitoring infants in the delivery room: a review. Arch Dis Child Fetal Neonatal Ed. 2007 Jan;92(1):F4-7. doi: 10.1136/adc.2006.102749. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse oximeter and co-oximeter readings	Pulse oximeter and co-oximeter reading pair used to determine the accuracy of each pulse oximeter. This will be achieved by evaluating root mean square (ARMS), bias, and precision of the readings.	Approximately 15 episodic minutes at the time of the blood draw