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

Masimo

Status: Terminated

Conditions: Anemia; Carbon Monoxide Poisoning

Treatments: Device: Pulse Oximeter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03017742

SUNE0002

Details and patient eligibility

About

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.

Enrollment: 813 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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813 participants in 1 patient group

Test Group

Experimental group

Description:

The subjects enrolled in the test group will receive the pulse oximeter

Treatment:

Device: Pulse Oximeter