NCT05250102

Neonatal Pulse Oximetry Sensor Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
DEVICE	Pulse oximeter sensors	Pulse oximeter reading will be compared to CO-oximeter reading.

Timeline

• Start date: 2022-06-13
• Primary completion: 2023-10-10
• Completion: 2023-10-10
• First posted: 2022-02-22
• Last updated: 2024-10-30
• Results posted: 2024-10-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study