Carbon Monoxide Measurement to Screen for Sickle Cell Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-12-31

Brief Summary

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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).

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Detailed Description

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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

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Sickle Cell Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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End-tidal Carbon Monoxide Subjects

Children between 1-18 years old with Sickle Cell Anemia

Group Type OTHER

End-tidal Carbon Monoxide Subjects

Intervention Type DEVICE

ETCO monitor will be used to measure CO levels in subjects and controls.

End-tidal Carbon Monoxide Controls

Healthy children age matched with subjects.

Group Type OTHER

End-tidal Carbon Monoxide Controls

Intervention Type DEVICE

ETCO monitor will be used to measure CO levels in subjects and controls.

Interventions

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End-tidal Carbon Monoxide Subjects

ETCO monitor will be used to measure CO levels in subjects and controls.

Intervention Type DEVICE

End-tidal Carbon Monoxide Controls

ETCO monitor will be used to measure CO levels in subjects and controls.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No