Background Evidence is lacking as to whether ambient light or phototherapy light could interfere with pulse oximeter performance.
Methods In this randomised cross-over trial, we recruited neonates of gestation >24 weeks. Consented infants were randomly assigned to either pulse oximeter sensor with opaque wrap or without opaque wrap. Nellcor and Masimo sensors were applied simultaneously to different feet for 10 min of recording. Infants were crossed over to the other intervention for a further 10 min, totalling 20 min recording per infant. Primary outcome was faster acquisition of data with shielding of pulse oximeter sensor as compared with not shielding.
Results A total of 96 babies were recruited. There was no difference in primary outcome of time taken to display valid data between the two groups (opaque wrap: 12.73±3.1 s vs no opaque wrap: 13.16±3.3 s, p=0.27). There was no difference in any of the secondary outcomes (percentage of valid data points, percentage of time saturation below target, and so on) between the two groups in both pulse oximeters. Masimo sensor readings displayed a higher mean oxygen saturation (mean difference of 2.85, p=0.001) and lower percentage of time saturation below 94% (mean difference of −27.8, p=0.001) than Nellcor in both groups. There was no difference in any of the outcomes in babies receiving phototherapy (n=21).
Conclusion In this study, shielding the pulse oximeter sensor from ambient light or phototherapy light did not yield faster data acquisition or better data quality.
Trial registration number ISRCTN10302534
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Contributors PKL was responsible for concept, design, data collection, interpretation of data, data analysis and drafting of initial manuscript. JEOS and JCB were responsible for design, interpretation of data and drafting of initial manuscript. CH was responsible for data collection, interpretation of data and drafting of initial manuscript. YR was responsible for interpretation of data and drafting of initial manuscript. SG was responsible for concept, design, interpretation of data and drafting of initial manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding The Research and Development Unit of University Hospital of North Tees funded the study.
Competing interests YR holds patents (US, EU, Japan) on technology that is being commercialised by Masimo and integrated into their oximeters. The technology is related to guiding oxygen titration during resuscitation in the delivery room and is not directly related to the work in this study.
Patient consent for publication Not required.
Ethics approval Written informed consent was obtained from the parents. The National Research Ethics Board approval (Integrated Research Application System) was obtained and the trial was registered. We used the Consolidated Standards of Reporting Trials (CONSORT) checklist for reporting.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. All the data were included in the manuscript and supplementary file. Access to raw data would be provided upon request.