Anemia Clinical Trial
Official title:
A Multi-Center Study on the Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in Emergency Department Patients
NCT number | NCT03017742 |
Other study ID # | SUNE0002 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | December 11, 2017 |
Verified date | June 2022 |
Source | Masimo Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Tepecik Training and Research Hospital IEC | Izmir |
Lead Sponsor | Collaborator |
---|---|
Masimo Corporation |
Turkey,
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 |
Status | Clinical Trial | Phase | |
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Terminated |
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