Carbon Monoxide Measurement to Screen for Sickle Cell Disease

Sickle Cell Anemia Clinical Trial

— SCDCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530242
• Other study ID #: 2015-013
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2021
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Anemia

Intervention

Device:
• End-tidal Carbon Monoxide Subjects
ETCO monitor will be used to measure CO levels in subjects and controls.
• End-tidal Carbon Monoxide Controls
ETCO monitor will be used to measure CO levels in subjects and controls.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UCSF Benioff Children's Hospital Oakland	Capnia, Inc.

References & Publications (1)

Lal A, Patterson L, Goldrich A, Marsh A. Point-of-care end-tidal carbon monoxide reflects severity of hemolysis in sickle cell anemia. Pediatr Blood Cancer. 2015 May;62(5):912-4. doi: 10.1002/pbc.25447. Epub 2015 Feb 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End-Tidal Carbon Monoxide	Compare ETCO between subjects and controls	1 hour

External Links

•   Journal Article - Point-of-care end-tidal carbon monoxide reflects severity of hemolysis in sickle cell anemia