Oxygen targeting in preterm infants using the Masimo SET Radical pulse oximeter

Area of Science:

• Neonatal medicine
• Clinical engineering
• Medical device technology

Background:

• A pretrial clinical improvement project for the BOOST-II UK trial identified an artefact in oxygen saturation profiles from Masimo SET Radical pulse oximeters.
• This artefact impacted saturation targeting in oxygen-dependent preterm infants.

Purpose of the Study:

• To investigate an artefact affecting Masimo SET Radical pulse oximeter saturation profiles.
• To evaluate the impact of revised software on oximeter accuracy and saturation distributions.

Main Methods:

• Saturation data were collected from 176 preterm infants over 2 weeks using Masimo SET Radical pulse oximeters.
• Frequency distributions of % time at each saturation were plotted.
• Revised software was installed, and saturation distributions were compared with four other oximeters in paired studies.

Main Results:

• The Masimo oximeter artefact reduced saturation values between 87-90% and artificially elevated higher values.
• Software revision (V4.8+) eliminated the artefact, improving saturation value distribution.
• Paired comparisons showed revised Masimo oximeters yielded saturation distributions similar to other commercial oximeters.

Conclusions:

• A software algorithm characteristic caused inaccurate saturation readings on the Masimo SET Radical pulse oximeter.
• Revised software (board firmware V4.8 or higher) corrects this artefact, ensuring accuracy within recommended standards.
• Consideration of this artefact is crucial for analyzing oxygen trial results and maximizing generalizability.