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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03017742
• Other study ID #: SUNE0002
• Status: Terminated
• Start date: November 2016
• Est. completion date: December 11, 2017

Study information

• Verified date: June 2022
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 813
• Est. completion date: December 11, 2017
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Carbon Monoxide Poisoning
• Emergencies
• Poisoning

Intervention

Device:
• Pulse Oximeter

Locations

Country	Name	City	State
Turkey	Tepecik Training and Research Hospital IEC	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Specificity of SpHb in Detecting Anemia.	Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.	up to 3 hours
Primary	Sensitivity of SpHb Detection of Anemia.	Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.	up to 3 hours
Primary	SpHb Utility for Screening Anemia	Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia	up to 3 hours