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N/A N=32 Diagnostic

Carbon Monoxide Measurement to Screen for Sickle Cell Disease

Sickle Cell Anemia

Bottom Line

View on ClinicalTrials.gov: NCT02530242 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: End-Tidal Carbon Monoxide — 4.35; .80 ppm

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
End-tidal Carbon Monoxide Subjects (Device); End-tidal Carbon Monoxide Controls (Device)
Age
Pediatric, Adult · 1+ yrs
Sex
All
Sponsor
UCSF Benioff Children's Hospital Oakland
Primary completion
Oct 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
End-Tidal Carbon Monoxide		 4.35; .80 —

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).

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
View full record on ClinicalTrials.gov →

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.

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