masimo Neonatal pulse oximetry
診斷與檢測

Study: Benefits of Critical Congenital Heart Disease (CCHD) Screening Using Masimo SET® Pulse Oximetry

Masimo announced the results of a prospective study published in the International Journal of Neonatal Screening in which researchers in Marrakesh, Morocco, conducted the first Moroccan study on critical congenital heart disease (CCHD) screening for newborns using Masimo SET® pulse oximetry.1 The authors concluded that “Our results encourage us to strengthen screening for CCHD by adding pulse oximetry to the routine newborn screening panel.”

Dr. Slitine and colleagues sought to improve early detection of CCHD in Morocco by studying the feasibility of implementing CCHD screening using pulse oximetry. From 三月 2019 to 一月 2020, 8,013 asymptomatic newborns at Mother and Child Hospital (part of the Mohammed VI University Hospital of Marrakesh), who were “normal” according to neonatal examination using the current standard, were screened for CCHD in accordance with American Academy of Pediatrics (AAP) guidelines, including pre- and post-ductal oxygen saturation measurement, using Masimo Rad-97® and Radical-7® Pulse CO-Oximeters® with Masimo SET® pulse oximetry sensors.

The researchers found that, of the 8,013 infants screened, 7,998 newborns had a negative screen (99.82%) and 15 newborns were screen positive (0.18%). Of those 15, five were later diagnosed with CCHD and five with non-critical CHD; five were false positives (three of which had other underlying conditions). Of the 7,998 infants who passed, there was one false negative, an infant who was later diagnosed, at 2 months of age, with coarctation of the aorta.

The researchers noted that the screening test was “easy, simple, reliable, reproducible, acceptable, discriminating, well-accepted by parents and caregivers, and did not involve parental anxiety.” They also noted that “Pulse oximetry has a good specificity and sensitivity and thereby fulfills the criteria for screening. Additionally, most of the data in the literature suggest a favorable cost-effectiveness of this technique.”

The authors concluded, “Screening for CCHD is a reliable method for the early detection of critical congenital heart disease and even non-cardiac conditions. We think that it will have positive repercussions on infant mortality and morbidity in Morocco. It is an optimal test and it adapts perfectly to our context. We hope to implement it locally and nationally, as consistent with international best practice for newborn screening, to allow for timely detection of the infants born with CCHD in Morocco.”

Although the researchers at times use the term pulse oximetry generally, the specific pulse oximetry technology used in this study, as noted, was Masimo SET®. To date, six other large published CCHD screening studies,2-7 as well as additional, smaller studies,8-9 have used Masimo SET®. Cumulatively, the large studies represent 284,800 infants, which includes the largest CCHD study to date, of 122,738 newborns.2 All of these CCHD studies with Masimo SET® pulse oximetry showed improved screening sensitivity with the use of Masimo SET® alongside clinical assessment when compared to routine physical exam alone. With its ability to accurately measure through motion and low perfusion, alongside its performance in outcome studies, Masimo SET® stands out as the established choice of pulse oximetry technology for clinicians and policymakers hoping to implement CCHD screening processes.10

參考文獻

  1. Slitine N, Bennaoui F, Sable C, Martin G, Hom L, Fadel A, Moussaoui S, Inajjarne N, Boumzebra D, Mouaffak Y, Younous S, Boukhanni L, Maoulainine F. Pulse Oximetry and Congenital Heart Disease Screening: Results of the First Pilot Study in Morocco. Int J Neonatal Screen 6(53). 30 六月 2020.
  2. Zhao et al. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.
  3. de-Wahl Granelli A 等。脈搏血氧飽和度篩檢對導管依賴型先天性心臟病檢測之影響：一項針對 39,821 名新生兒的瑞典前瞻性篩檢研究。《英國醫學期刊》（BMJ）。2009 年1 月 8 日；第 338 期。
  4. Ewer AK et al. Pulse Oximetry Screening for Congenital Heart Defects in Newborn Infants (Pulseox): A Test Accuracy Study. Lancet. 2011 Aug 27;378(9793):785-94.
  5. de-Wahl Granelli A et al. Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening for Critical Left Heart Obstruction. Acta Paediatr 2007; 96(10): 1455-9.
  6. Meberg A et al. First Day of Life Pulse Oximetry Screening to Detect Congenital Heart Defects. J Pediatr 2008; 152:761-5.
  7. Schena F et al. Perfusion Index and Pulse Oximetry Screening for Congenital Heart Defects. J Pediatr. 2017 Apr;183:74-79.
  8. Hamilçıkan S, Can E. Critical Congenital Heart Disease Screening With a Pulse Oximetry in Neonates. J Perinat Med. 2018 Feb 23;46(2):203-207.
  9. Jawin V et al. Beyond Critical Congenital Heart Disease: Newborn Screening Using Pulse Oximetry for Neonatal Sepsis and Respiratory Diseases in a Middle-Income Country. PLoS One. 2015; 10(9): e0137580.
  10. 有關脈搏血氧飽和度監測及 MasimoSET®優勢的已發表臨床研究，可於我們的網站http://www.masimo.com 上查閱。這些比較研究包含獨立且客觀的研究，內容涵蓋於科學會議上發表的摘要以及經同儕審查的期刊文章。
  11. Castillo A 等。透過臨床實務調整與SpO₂技術預防早產兒視網膜病變。《小兒科雜誌》（Acta Paediatr.）。2011年 2 月；100(2)：188-92。
  12. Taenzer AH et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
  13. Taenzer A 等。術後監測——達特茅斯經驗。《麻醉與病患安全基金會通訊》。2012 年春夏號。
  14. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
  15. 估計值：Masimo 存檔資料。
  16. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview。

Source: Masimo

 

發表回覆