Carbon Monoxide Measurement to Screen for Sickle Cell Disease

Study Overview
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Brief Summary
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Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).

Detailed Description
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Increase the temperature operating range of ETCO measurements to 5 to 45°C. The signal output-to-CO (carbon monoxide) concentration correlation of the CO sensor is dependent on temperature. The new algorithm will be a different approach because the current algorithm is at the limits of its capability. We will establish the new specifications by determining performance in a bench model under simulated temperature conditions. We will then determine the ability of the modified device to distinguish between SCD and healthy controls. During this initial testing, we will examine the validity of ETCO measurements under regulated room temperature in the hospital setting. We will enroll 20 subjects, 10 each in the SCD arm and control arm to determine the mean and variance of the ETCO values.

Official Title
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Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease

Conditions
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Sickle Cell Anemia

Intervention / Treatment
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* Device: End-tidal Carbon Monoxide Subjects
* Device: End-tidal Carbon Monoxide Controls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parental / legal guardian consent Subject assent for participants ages 7 and above Male and female children ages 1-18 years old For Hb SS (Homozygous sickle cell anemia) subjects, hemoglobin baseline hemoglobin ≤10 g/dL based upon average hemoglobin value in past year Exclusion Criteria: Subjects must not meet any of the following exclusion criteria to be considered eligible for study enrollment: Had a red blood cell transfusion within 8 weeks prior to enrollment Currently a primary smoker or was a primary smoker within 4 weeks prior to enrollment Exposed to second hand smoke within 24 hours prior to breath sample collections Have current upper respiratory infection or symptomatic asthma For healthy subjects, known to have the sickle cell trait by electrophoresis or genetic testing

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: End-tidal Carbon Monoxide Subjects<br>Children between 1-18 years old with Sickle Cell Anemia | Device: End-tidal Carbon Monoxide Subjects<br>* ETCO monitor will be used to measure CO levels in subjects and controls.<br>|
| Other: End-tidal Carbon Monoxide Controls<br>Healthy children age matched with subjects. | Device: End-tidal Carbon Monoxide Controls<br>* ETCO monitor will be used to measure CO levels in subjects and controls.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-Tidal Carbon Monoxide | Compare ETCO between subjects and controls | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sickle Cell Anemia