NCT02530242

Carbon Monoxide Measurement to Screen for Sickle Cell Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: UCSF Benioff Children's Hospital Oakland · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Anemia

Interventions

Type	Name	Description
DEVICE	End-tidal Carbon Monoxide Subjects	ETCO monitor will be used to measure CO levels in subjects and controls.
DEVICE	End-tidal Carbon Monoxide Controls	ETCO monitor will be used to measure CO levels in subjects and controls.

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2015-08-21
• Last updated: 2021-06-09
• Results posted: 2020-10-19