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Accuracy of a portable pulse oximeter in monitoring hypoxemic infants with cyanotic heart disease

Published online by Cambridge University Press:  15 July 2019

Bronwyn U. Harris ,
Sarah Stewart ,
Archana Verma ,
Helena Hoen ,
Mary Lyn Stein ,
Gail Wright  and
Chandra Ramamoorthy
Bronwyn U. Harris*
Affiliation:
Departments of Pediatrics (Cardiology), Stanford University School of Medicine, Palo Alto, CA, USA
Sarah Stewart
Affiliation:
Departments of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA
Archana Verma
Affiliation:
Departments of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA
Helena Hoen
Affiliation:
Quantitative Sciences Unit, Stanford University School of Medicine, Palo Alto, CA, USA
Mary Lyn Stein
Affiliation:
Departments of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA Anesthesiology and Critical care (Pediatric Anesthesiology), Stanford University School of Medicine, Palo Alto, CA, USA
Gail Wright
Affiliation:
Departments of Pediatrics (Cardiology), Stanford University School of Medicine, Palo Alto, CA, USA
Chandra Ramamoorthy
Affiliation:
Departments of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA
*
Author for correspondence: B. U. Harris, Departments of Pediatrics (Cardiology), Stanford University School of Medicine, Palo Alto, CA, USA; E-mail: [email protected]
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Abstract

Objective:

Infants with single ventricle physiology have arterial oxygen saturations between 75 and 85%. Home monitoring with daily pulse oximetry is associated with improved interstage survival. They are typically sent home with expensive, bulky, hospital-grade pulse oximeters. This study evaluates the accuracy of both the currently used Masimo LNCS and a relatively inexpensive, portable, and equipped with Bluetooth technology study device, by comparing with the gold standard co-oximeter.

Design:

Prospective, observational study.

Setting:

Single institution, paediatric cardiac critical care unit, and neonatal ICU.

Interventions:

none.

Patients:

Twenty-four infants under 12 months of age with baseline oxygen saturation less than 90% due to cyanotic CHD.

Measurements and Results:

Pulse oximetry with WristOx2 3150 with infant sensors 8008 J (study device) and Masimo LCNS saturation sensor connected to a Philips monitor (hospital device) were measured simultaneously and compared to arterial oxy-haemoglobin saturation measured by co-oximetry. Statistical analysis evaluated the performances of each and compared to co-oximetry with Schuirmann’s TOST equivalence tests, with equivalence defined as an absolute difference of 5% saturation or less. Neither the study nor the hospital device met the predefined standard for equivalence when compared with co-oximetry. The study device reading was on average 4.0% higher than the co-oximeter, failing to show statistical equivalence (p = 0.16). The hospital device was 7.4% higher than the co-oximeter and also did not meet the predefined standard for equivalence (p = 0.97).

Conclusion:

Both devices tended to overestimate oxygen saturation in this patient population when compared to the gold standard, co-oximetry. The study device is at least as accurate as the hospital device and offers the advantage of being more portable with Bluetooth technology that allows reliable, efficient data transmission. Currently FDA-approved, smaller portable pulse oximeters can be considered for use in home monitoring programmes.

Keywords

Pulse oximetrymonitoringhypoxiapaediatriccongenital heart disease/defectshome monitoring
Type
Original Article
Information
Cardiology in the Young , Volume 29 , Issue 8 , August 2019 , pp. 1025 - 1029
Copyright
© Cambridge University Press 2019 

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