Neonatal Pulse Oximetry Sensor Study

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Device: Pulse oximeter sensors

• Registration Number: NCT05250102
• Lead Sponsor: Medline Industries

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-22
• Study Start: 2022-06-13
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10
• Status Verified: 2024-10
• Results First Submitted: 2024-10-02
• Results First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Results First Posted: 2024-10-30
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulse oximeter sensor readings	Pulse oximeter sensors	Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate.

Primary Outcome Measures

Name	Time	Method
Bland-Altman Analysis for Nellcor Pulse Oximeter	15 episodic minutes	BIAS Measurement and 95% confidence interval calculated using a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error plot (SaO2 vs. difference of SaO2 and SpO2) were generated. The B\&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot. We ran a percentage mean difference plot.

Trial Locations

Locations (2)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Eastern Carolina University; 🇺🇸 Greenville, North Carolina, United States