Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department

Study Overview
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Brief Summary
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The purpose of this study is to determine the clinical utility of triage screening for anemia and carbon monoxide poisoning (COP) in the ED setting.This is a prospective, nonrandomized, multi-center study of the performance of simultaneous non-invasive testing for two common disorders (COP and anemia). We will determine the limits of agreement and performance characteristics of non-invasive carboxyhemoglobin (SpCO) and hemoglobin (SpHb) values compared to standard blood tests for measurement of carboxyhemoglobin and hemoglobin, in the emergency department setting.

Official Title
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A Multi-Center Study on the Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in Emergency Department Patients

Conditions
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Carbon Monoxide Poisoning, Anemia

Intervention / Treatment
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* Device: Pulse Oximeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 1 year or older. At least one digit has acceptable width as measured by study-provided digit gauge. Presenting to emergency department for any complaint. Potential for IV catheter and/or blood draw for CBC as standard of care. Exclusion Criteria: Patients unable to consent for any reason Patients with fingernail polish, discoloration or trauma to fingers

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>The subjects enrolled in the test group will receive the pulse oximeter | Device: Pulse Oximeter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference Between SpCO and COHb | Measure the difference between noninvasive carboxyhemoglobin (SpCO) and carboxyhemoglobin determined by co-oximeter measurement of blood (COHb) as calculated in terms of standard deviation. The average difference between paired Masimo noninvasive carboxyhemoglobin (SpCO) and reference carboxyhemoglobin (COHb) determined by co-oximeter measurement of blood represented as mean bias. | Up to 3 hours | 
| SpCO Detection of Carbon Monoxide Poisoning (COP) | Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb. | up to 3 hours | 
| Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning | Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity | up to 3 hours | 
| Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration | CO elimination will be evaluated as a function of administered oxygen. | up to 3 hours | 
| Specificity of SpHb in Detecting Anemia. | Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer. | up to 3 hours | 
| Sensitivity of SpHb Detection of Anemia. | Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer. | up to 3 hours | 
| SpHb Utility for Screening Anemia | Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia | up to 3 hours |