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

June 14, 2022 updated by: Masimo Corporation

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

813

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey, 468
        • Tepecik Training and Research Hospital IEC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference Between SpCO and COHb
Time Frame: 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.
Up to 3 hours
SpCO Detection of Carbon Monoxide Poisoning (COP)
Time Frame: up to 3 hours
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
Time Frame: up to 3 hours
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
Time Frame: up to 3 hours
CO elimination will be evaluated as a function of administered oxygen.
up to 3 hours
Specificity of SpHb in Detecting Anemia.
Time Frame: up to 3 hours
Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
up to 3 hours
Sensitivity of SpHb Detection of Anemia.
Time Frame: up to 3 hours
Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.
up to 3 hours
SpHb Utility for Screening Anemia
Time Frame: up to 3 hours
Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia
up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

December 11, 2017

Study Completion (Actual)

December 11, 2017

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUNE0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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