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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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