An interventional study of End-tidal Carbon Monoxide Subjects and End-tidal Carbon Monoxide Controls in Sickle Cell Anemia, sponsored by UCSF Benioff Children's Hospital Oakland. Completed. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by UCSF Benioff Children's Hospital Oakland · Not applicable, Interventional, and Diagnostic
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).
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.
1,125 studies on the registry are indexed under Anemia, Sickle Cell; 239 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 762 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 55 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Children between 1-18 years old with Sickle Cell Anemia
Device: End-tidal Carbon Monoxide Subjects
Healthy children age matched with subjects.
Device: End-tidal Carbon Monoxide Controls
ETCO monitor will be used to measure CO levels in subjects and controls.
ETCO monitor will be used to measure CO levels in subjects and controls.
End-Tidal Carbon Monoxide
Compare ETCO between subjects and controls
Time frame: 1 hour
| Milestone | End-tidal Carbon Monoxide Subjects | End-tidal Carbon Monoxide Controls |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 15 |
| Not completed | 0 | 1 |
| Withdrew: Excluded due to asthma and oxcarbazepine | 0 | 1 |
Compare ETCO between subjects and controls
| ppm | End-tidal Carbon Monoxide Subjects | End-tidal Carbon Monoxide Controls |
|---|---|---|
| End-Tidal Carbon Monoxide | 4.35 (1.8 to 9.7) | .80 (.2 to 2.3) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| End-tidal Carbon Monoxide Subjects | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| End-tidal Carbon Monoxide Controls | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(years) | End-tidal Carbon Monoxide Subjects | End-tidal Carbon Monoxide Controls | Total |
|---|---|---|---|
| Mean | 9.4 (5 to 14) | 9.7 (5 to 14) | 9.5 (5 to 14) |
| Sex: Female, Male(Participants) | End-tidal Carbon Monoxide Subjects | End-tidal Carbon Monoxide Controls | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 5 | 5 | 10 |
| Race and Ethnicity Not Collected(Participants) | End-tidal Carbon Monoxide Subjects | End-tidal Carbon Monoxide Controls | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | End-tidal Carbon Monoxide Subjects | End-tidal Carbon Monoxide Controls | Total |
|---|---|---|---|
| United States | 16 | 16 | 32 |
No study locations are listed for this record.
The record gives a start of Jul 2015, a primary completion of Oct 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2020, 5 years after primary completion.
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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UCSF Benioff Children's Hospital Oakland