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

Terminated

• Conditions: Carbon Monoxide Poisoning; Anemia
• Interventions: Device: Pulse Oximeter

• Registration Number: NCT03017742
• Lead Sponsor: Masimo Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Disposition First Submitted: 2019-01-10
• Disposition First Submitted QC: 2019-01-10
• Results First Submitted: 2021-08-30
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-14
• Last Update Submitted: 2022-06-14
• Results First Posted: 2022-07-08
• Disposition First Posted: 2022-07-08
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 813

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Group	Pulse Oximeter	The subjects enrolled in the test group will receive the pulse oximeter

Primary Outcome Measures

Name	Time	Method
SpCO Detection of Carbon Monoxide Poisoning (COP)	up to 3 hours	Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.
Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning	up to 3 hours	Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity
SpHb Utility for Screening Anemia	up to 3 hours	Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia
Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration	up to 3 hours	CO elimination will be evaluated as a function of administered oxygen.
Specificity of SpHb in Detecting Anemia.	up to 3 hours	Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
Difference Between SpCO and COHb	Up to 3 hours	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.
Sensitivity of SpHb Detection of Anemia.	up to 3 hours	Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.

Trial Locations

Locations (1)

Tepecik Training and Research Hospital IEC; 🇹🇷 Izmir, Turkey