Trial Outcomes & Findings for Carbon Monoxide Measurement to Screen for Sickle Cell Disease (NCT NCT02530242)
NCT ID: NCT02530242
Last Updated: 2021-06-09
Results Overview
Compare ETCO between subjects and controls
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
1 hour
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
excluded due to asthma and oxcarbazepine
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
End-tidal Carbon Monoxide Subjects
n=16 Participants
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.
|
End-tidal Carbon Monoxide Controls
n=16 Participants
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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.4 years
n=16 Participants
|
9.7 years
n=16 Participants
|
9.5 years
n=32 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=16 Participants
|
11 Participants
n=16 Participants
|
22 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=16 Participants
|
5 Participants
n=16 Participants
|
10 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: 1 hourCompare ETCO between subjects and controls
Outcome measures
| Measure |
End-tidal Carbon Monoxide Subjects
n=16 Participants
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.
|
End-tidal Carbon Monoxide Controls
n=15 Participants
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.
|
|---|---|---|
|
End-Tidal Carbon Monoxide
|
4.35 ppm
Interval 1.8 to 9.7
|
.80 ppm
Interval 0.2 to 2.3
|
Adverse Events
End-tidal Carbon Monoxide Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
End-tidal Carbon Monoxide Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place