Neonatal Pulse Oximetry Sensor Study

Medline Industries

Status: Completed

Conditions: Premature Birth

Treatments: Device: Pulse oximeter sensors

Study type: Interventional

Funder types: Industry

Identifiers

NCT05250102

MED-2020-DIV65-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Pulse oximeter sensor readings

Other group

Description:

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.

Treatment:

Device: Pulse oximeter sensors