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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | The subjects enrolled in the test group will receive the pulse oximeter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse Oximeter | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Specificity of SpHb in Detecting Anemia. | Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer. | up to 3 hours |
| Sensitivity of SpHb Detection of Anemia. | Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer. | up to 3 hours |
| SpHb Utility for Screening Anemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tepecik Training and Research Hospital IEC | Izmir | 468 | Turkey (Türkiye) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Group | The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Group | The subjects enrolled in the test group will receive the pulse oximeter Pulse Oximeter |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 140 subjects excluded due to: 35 subjects: no valid reference COHb measurements available 17 subjects: no SpCO measurements available 65 subjects: COHb sample more than 10 minutes from the SpCO measurement. 22 subjects: low SpCO confidence value 1 subject: invalid reference measurement (COHb) Target subject sample size of 3000 was not met to evaluate difference between SpCO and COHb. The results are reported in terms of standard deviation. | Posted | Mean | Standard Deviation | percent | Up to 3 hours |
|
Adverse events were monitored throughout study duration, which was up to three hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Group | The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Johnson | Masimo Corporation | (949) 297-7000 | clinicalresearchdept@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2016 | Aug 30, 2021 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002249 | Carbon Monoxide Poisoning |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D005739 | Gas Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D006402 | Hematologic Diseases |
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Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia |
| up to 3 hours |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters |
|
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| Primary | SpCO Detection of Carbon Monoxide Poisoning (COP) | Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb. | Out of the 600 subjects that were analyzed from all that were enrolled, only 26 subjects met the criteria for carbon monoxide poisoning. | Posted | Number | percentage | up to 3 hours |
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| Primary | Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning | Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity | Clinician survey were not conducted or collected to perform data analysis. | Posted | up to 3 hours |
|
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| Primary | Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration | CO elimination will be evaluated as a function of administered oxygen. | No COHb elimination pharmacokinetics data was collected. | Posted | up to 3 hours |
|
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| Primary | Specificity of SpHb in Detecting Anemia. | Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer. | Excluded subjects are shown below: 20 subjects: no valid blood reference results 73 subjects: time between the first valid SpHb reading and the venous blood draw exceeded 10 minutes. 32 subjects: low Perfusion Index quality. 3 subjects: low signal stability 26 subjects: low SpHb confidence 18 subjects : no SpHb result displayed. 21 subjects: user error 1 subject: pregnant | Posted | Number | percentage of true negative | up to 3 hours |
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| Primary | Sensitivity of SpHb Detection of Anemia. | Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer. | Excluded subjects are shown below: 20 subjects: no valid blood reference results 73 subjects: time between the first valid SpHb reading and the venous blood draw exceeded 10 minutes. 32 subjects: low Perfusion Index quality. 3 subjects: low signal stability 26 subjects: low SpHb confidence 18 subjects : no SpHb result displayed. 21 subjects: user error 1 subject: pregnant | Posted | Number | percent of true positives | up to 3 hours |
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| Primary | SpHb Utility for Screening Anemia | Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia | The number of subjects requirement defined by the study protocol were not met in this study, thus the threshold that predicts the outcome of "acute treatment of anemia" cannot be determined nor validated. | Posted | up to 3 hours |
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| 0 |
| 813 |
| 0 |
| 813 |
| 0 |
| 813 |
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| D006425 |
| Hemic and Lymphatic Diseases |