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

Masimo Corporation813 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

813

Conditions

Carbon Monoxide Poisoning Anemia

Interventions

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: up to 3 hours

Specificity of SpHb in Detecting Anemia.

Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.

Time frame: up to 3 hours

Sensitivity of SpHb Detection of Anemia.

Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.

Time frame: up to 3 hours

SpHb Utility for Screening Anemia

Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia

Time frame: up to 3 hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes