Toxicology/original researchAccuracy of Noninvasive Multiwave Pulse Oximetry Compared With Carboxyhemoglobin From Blood Gas Analysis in Unselected Emergency Department Patients
Introduction
Carbon monoxide (CO) poisoning is a major cause of morbidity and mortality. Official data from the United States indicate approximately 20,000 exposures1 and 439 deaths2 per year, including only non−fire-related and unintentional cases. Large registry trials, however, show much higher numbers than those officially reported, with approximately 50,000 visits per year to emergency departments (EDs) alone, representing 0.05% of all patients.3, 4 Data from other countries are limited, but higher rates than in the United States are expected.5
Symptoms of CO poisoning are nonspecific, ranging from mild headache, nausea, confusion, and dizziness to end-organ injury such as myocardial infarction,6 stroke,7 and death.8, 9 Diagnosis is therefore difficult and relies on clinical suspicion and confirmation by measurement of carboxyhemoglobin (COHb), using either venous or arterial10 blood gas analysis. However, COHb analyzers are not ubiquitously available.11 As a result, many victims of CO poisoning might be overlooked and misdiagnosed.12, 13
Conventional pulse oximetry uses 2 different wavelengths of light only and is not able to explicitly determine COHb or methemoglobin levels, leading to wrong results.14 Recent technologic advancements allow for noninvasive measurement of COHb by multiwave pulse oximetry.15 Multiwave pulse oximeters use 8 different wavelengths to overcome this problem. This technique has been tested on healthy volunteers15 and small groups of selected patients.16, 17, 18, 19 To date, however, the accuracy of this method has not been studied in daily clinical use with large numbers of unselected patients.
The aim of our study was to assess bias and precision of multiwave pulse oximetry compared with blood gas analysis as reference standard in a cohort of unselected patients presenting to a large tertiary care ED. We further aimed to identify the upper limit of normal cutoff values of noninvasively measured COHb to aid in the diagnosis of CO poisoning and identify factors that influence its accuracy. Subgroup analyses were performed for smokers and nonsmokers.
Section snippets
Study Design and Setting
The study was performed as a prospective cohort-type study according to the STARD (Standards for the Reporting of Diagnostic accuracy studies) statement for reporting studies of diagnostic accuracy.20 It was conducted at a tertiary care 2,000-bed university hospital ED with a census of 30,000 patient visits per year. The study was approved by our institutional review board for human studies, with a waived written informed consent.
Selection of Participants and Interventions
For the purpose of this study, we replaced the standard pulse
Results
A total of 2,292 patients receiving both blood gas analysis (arterial or venous) and noninvasive multiwave pulse oximetry were eligible for the study. Seven hundred fourteen patients were excluded because time between CO oximetry and blood gas analysis exceeded 60 minutes, resulting in 1,578 patients finally included (Table 1; Figure 2A and B). SpCO values ranged from 0% to 50% (median 3% SpCO; interquartile range 5% SpCO) and COHb values from 0% to 39.3% (median 0.9% COHb; interquartile range
Limitations
Compared with the large population used for the calculation of bias and precision, the number of patients actually found to be poisoned was small, especially in the group of poisoned smokers. Therefore, the opportunity for false-negative results was limited. Because a false-negative reading could have serious medical consequences, this device should be tested in a much larger number of poisoned patients to confirm the generalizability of our stated cutoff values. Despite intensive staff
Discussion
In a cohort of consecutive unselected ED patients, we found a bias between SpCO and COHb of 2.99% and a precision of 3.27%. There are currently no standards of acceptable bias and precision of COHb measurements. However, conventional pulse oximetry, which is a widely used and accepted tool, has been shown to measure oxyhemoglobin with a bias of −0.02% and a precision of 2.10% compared with blood gas analysis.23 As a result, a bias of 2% to 4% seems acceptable to us for the detection of high
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2017, Annals of Emergency MedicineCitation Excerpt :Two additional Class III studies22,23 explored noninvasive CO oximetry with convenience sampling of undifferentiated patients. A 2011 study by Roth et al22 identified 1,578 patients with noninvasive CO oximetry screening tests who also had blood COHb testing within 60 minutes of the noninvasive measurement. Only 17 of 1,578 study patients received a diagnosis of CO poisoning (1.1%; 95% CI 0.6% to 1.7%), limiting the conclusions that can be drawn from this study.
Supervising editors: Matthew D. Sztajnkrycer, MD, PhD; Richard C. Dart, MD, PhD
Author contributions: DR drafted the study protocol and the article. DR and CH conducted the literature search and participated in data acquisition. HH, WS, GG, ANL, and CH critically revised the study protocol. HH, WS, NH, GG, ANL, and CH critically revised the article for important intellectual content. DR, HH, and NH were responsible for statistical analysis. WS and NH participated in data acquisition. ANL supervised clinical implementation. CH supervised the project. All authors gave final approval of the article. CH takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). Equipment, Masimo Radical-7, was provided by Masimo Inc. Mr. Roth and Dr. Hubmann were paid by a grant from Masimo Inc. Masimo had no influence on the design, conduct, or publication of this study whatsoever.
Publication date: Available online April 2, 2011.
Please see page 75 for the Editor's Capsule Summary of this article.
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