Randomised crossover study on pulse oximeter readings from different sensors in very preterm infants.

Autor: Maiwald CA; Department of Pediatrics, Center for Pediatric Clinical Studies (CPCS), University Hospital Tübingen, Tübingen, Germany.; Department of Neonatology, Tübingen University Hospital, Tübingen, Germany., Schwarz CE; Department of Neonatology, Tübingen University Hospital, Tübingen, Germany.; Department of Neonatology, University of Heidelberg, Heidelberg, Germany., Böckmann K; Department of Neonatology, Tübingen University Hospital, Tübingen, Germany., Springer L; Department of Neonatology, Tübingen University Hospital, Tübingen, Germany., Poets CF; Department of Neonatology, Tübingen University Hospital, Tübingen, Germany christian-f.poets@med.uni-tuebingen.de., Franz A; Department of Pediatrics, Center for Pediatric Clinical Studies (CPCS), University Hospital Tübingen, Tübingen, Germany.; Department of Neonatology, Tübingen University Hospital, Tübingen, Germany.
Jazyk: angličtina
Zdroj: Archives of disease in childhood. Fetal and neonatal edition [Arch Dis Child Fetal Neonatal Ed] 2024 Jun 19; Vol. 109 (4), pp. 391-396. Date of Electronic Publication: 2024 Jun 19.
DOI: 10.1136/archdischild-2023-325961
Abstrakt: Objective: In extremely preterm infants, different target ranges for pulse oximeter saturation (SpO 2 ) may affect mortality and morbidity. Thus, the impact of technical changes potentially affecting measurements should be assessed. We studied SpO 2 readings from different sensors for systematic deviations.
Design: Single-centre, randomised, triple crossover study.
Setting: Tertiary neonatal intensive care unit.
Patients: 24 infants, born at <32 weeks' gestation, with current weight <1500 g and without right-to-left shunt via a patent ductus arteriosus.
Interventions: Simultaneous readings from three SpO 2 sensors (Red Diamond (RD), Photoplethysmography (PPG), Low Noise Cabled Sensors (LNCS)) were logged at 0.5 Hz over 6 hour/infant and compared with LNCS as control using analysis of variance. Sensor position was randomly allocated and rotated every 2 hours. Seven different batches each were used.
Outcomes: Primary outcome was the difference in SpO 2 readings. Secondary outcomes were differences between sensors in the proportion of time within the SpO 2 -target range (90-95 (100)%).
Results: Mean gestational age at birth (±SD) was 27 4/7 (±2 3/7 ) weeks, postnatal age 20 (±20) days. 134 hours of recording were analysed. Mean SpO 2 (±SD) was 94.0% (±3.8; LNCS) versus 92.2% (±4.0; RD; p<0.0001) and 94.5% (±3.9; PPG; p<0.0001), respectively. Mean SpO 2 difference (95% CI) was -1.8% (-1.9 to -1.8; RD) and 0.5% (0.4 to 0.5; PPG). Proportion of time in target was significantly lower with RD sensors (84.8% vs 91.7%; p=0.0001) and similar with PPG sensors (91.1% vs 91.7%; p=0.63).
Conclusion: There were systematic differences in SpO 2 readings between RD sensors versus LNCS. These findings may impact mortality and morbidity of preterm infants, particularly when aiming for higher SpO 2 -target ranges (eg, 90-95%).
Trial Registration Number: DRKS00027285.
Competing Interests: Competing interests: CFP received advisory board-honoraria from Masimo, Irvine, California in 09/2020. All other authors have indicated they have no conflicts of interests relevant to this article to disclose. AF and CFP declare that Masimo generously supported SpO2 measurements in a previous and an ongoing clinical trial. In this study, Masimo provided also the required LNCS, RD and PPG sensors. However, Masimo had no impact on the design of this study, analysis of the data and writing of this manuscript.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze: MEDLINE
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