N/A
Completed N=32
Carbon Monoxide Measurement to Screen for Sickle Cell Disease
Source: ClinicalTrials.gov NCT02530242 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: End-Tidal Carbon Monoxide — 4.35; .80 ppm
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY End-Tidal Carbon Monoxide |
4.35; .80 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02530242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.