Sickle Cell Anemia
Conditions
Keywords
Sickle Cell Anemia
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.
Interventions
DEVICEEnd-tidal Carbon Monoxide Subjects
ETCO monitor will be used to measure CO levels in subjects and controls.
DEVICEEnd-tidal Carbon Monoxide Controls
ETCO monitor will be used to measure CO levels in subjects and controls.
Sponsors
Capnia, Inc.
UCSF Benioff Children's Hospital Oakland
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End-Tidal Carbon Monoxide | 1 hour | Compare ETCO between subjects and controls |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| End-tidal Carbon Monoxide Subjects Children between 1-18 years old with Sickle Cell Anemia
End-tidal Carbon Monoxide Subjects: ETCO monitor will be used to measure CO levels in subjects and controls. | 16 |
| End-tidal Carbon Monoxide Controls Healthy children age and gender matched with subjects.
End-tidal Carbon Monoxide Controls: ETCO monitor will be used to measure CO levels in subjects and controls. | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | excluded due to asthma and oxcarbazepine | 0 | 1 |
Baseline characteristics
| Characteristic | End-tidal Carbon Monoxide Controls | Total | End-tidal Carbon Monoxide Subjects |
|---|---|---|---|
| Age, Continuous | 9.7 years | 9.5 years | 9.4 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 16 participants | 32 participants | 16 participants |
| Sex: Female, Male Female | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
End-Tidal Carbon Monoxide
Compare ETCO between subjects and controls
Time frame: 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| End-tidal Carbon Monoxide Subjects | End-Tidal Carbon Monoxide | 4.35 ppm |
| End-tidal Carbon Monoxide Controls | End-Tidal Carbon Monoxide | .80 ppm |