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

Primary Purpose

Carbon Monoxide Poisoning, Anemia

Status
Terminated
Phase
Locations
Turkey
Study Type
Interventional
Intervention
Pulse Oximeter
Sponsored by
Masimo Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carbon Monoxide Poisoning

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tepecik Training and Research Hospital IEC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
SpCO Detection of Carbon Monoxide Poisoning (COP)
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
Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity
Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration
CO elimination will be evaluated as a function of administered oxygen.
Specificity of SpHb in Detecting Anemia.
Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
Sensitivity of SpHb Detection of Anemia.
Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.
SpHb Utility for Screening Anemia
Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia

Secondary Outcome Measures

Full Information

First Posted
January 9, 2017
Last Updated
June 14, 2022
Sponsor
Masimo Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03017742
Brief Title
Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department
Official Title
A Multi-Center Study on the Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in Emergency Department Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 11, 2017 (Actual)
Study Completion Date
December 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbon Monoxide Poisoning, Anemia

7. Study Design

Primary Purpose
Other
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
813 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
The subjects enrolled in the test group will receive the pulse oximeter
Intervention Type
Device
Intervention Name(s)
Pulse Oximeter
Primary Outcome Measure Information:
Title
Difference Between SpCO and COHb
Description
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.
Time Frame
Up to 3 hours
Title
SpCO Detection of Carbon Monoxide Poisoning (COP)
Description
Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.
Time Frame
up to 3 hours
Title
Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning
Description
Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity
Time Frame
up to 3 hours
Title
Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration
Description
CO elimination will be evaluated as a function of administered oxygen.
Time Frame
up to 3 hours
Title
Specificity of SpHb in Detecting Anemia.
Description
Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
Time Frame
up to 3 hours
Title
Sensitivity of SpHb Detection of Anemia.
Description
Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.
Time Frame
up to 3 hours
Title
SpHb Utility for Screening Anemia
Description
Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia
Time Frame
up to 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tepecik Training and Research Hospital IEC
City
Izmir
ZIP/Postal Code
468
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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