Carbon Monoxide Measurement to Screen for Sickle Cell Disease

Not Applicable

Completed

• Conditions: Sickle Cell Anemia
• Interventions: Device: End-tidal Carbon Monoxide Subjects; Device: End-tidal Carbon Monoxide Controls

• Registration Number: NCT02530242
• Lead Sponsor: UCSF Benioff Children's Hospital Oakland

Brief 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).

Detailed Description

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Results First Submitted: 2020-09-23
• Results First Submitted QC: 2020-09-23
• Results First Posted: 2020-10-19
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
End-tidal Carbon Monoxide Subjects	End-tidal Carbon Monoxide Subjects	Children between 1-18 years old with Sickle Cell Anemia
End-tidal Carbon Monoxide Controls	End-tidal Carbon Monoxide Controls	Healthy children age matched with subjects.

Primary Outcome Measures

Name	Time	Method
End-Tidal Carbon Monoxide	1 hour	Compare ETCO between subjects and controls