Sickle Cell AnemiaSCDCONCT02530242
Carbon Monoxide Measurement to Screen for Sickle Cell Disease
A study testing End-tidal Carbon Monoxide Subjects in people with Sickle Cell Anemia, run by UCSF Benioff Children's Hospital Oakland.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- End-tidal Carbon Monoxide Subjects
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Subjects must not meet any of the following exclusion criteria to be considered eligible for study enrollment:
- 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
About this study
Official title: Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease
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).
Read the 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
- Being tested
- End-tidal Carbon Monoxide Subjects, End-tidal Carbon Monoxide Controls
- Keywords
- Sickle Cell Anemia
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-tidal Carbon Monoxide SubjectsDevice
ETCO monitor will be used to measure CO levels in subjects and controls.
End-tidal Carbon Monoxide ControlsDevice
ETCO monitor will be used to measure CO levels in subjects and controls.
| Study group | Role | What they receive |
|---|---|---|
| End-tidal Carbon Monoxide Subjects | Other | Children between 1-18 years old with Sickle Cell Anemia Receives: Device: End-tidal Carbon Monoxide Subjects |
| End-tidal Carbon Monoxide Controls | Other | Healthy children age matched with subjects. Receives: Device: End-tidal Carbon Monoxide Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-Tidal Carbon Monoxide
Compare ETCO between subjects and controls
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- Capnia, Inc.
- Responsible party
- Sponsor
- Investigators
- Ashutosh Lal, MD, Principal investigator, Children's Hospital & Research Center at Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530242
- Sponsor's protocol ID
- 2015-013
- Acronym
- SCDCO
- Status last verified
- May 2021
- First submitted
- 19 Aug 2015
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lal A, Patterson L, Goldrich A, Marsh A. Point-of-care end-tidal carbon monoxide reflects severity of hemolysis in sickle cell anemia. Pediatr Blood Cancer. 2015 May;62(5):912-4. doi: 10.1002/pbc.25447. Epub 2015 Feb 14.
PubMed 25683629
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02530242
- Acronym / sponsor ID
- SCDCO / 2015-013
- Conditions
- Sickle Cell Anemia
- Keywords
- Sickle Cell Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- Capnia, Inc.
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-tidal Carbon Monoxide Subjects | Other | Device: End-tidal Carbon Monoxide SubjectsChildren between 1-18 years old with Sickle Cell Anemia |
| End-tidal Carbon Monoxide Controls | Other | Device: End-tidal Carbon Monoxide ControlsHealthy children age matched with subjects. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Subjects must not meet any of the following exclusion criteria to be considered eligible for study enrollment:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| End-tidal Carbon Monoxide SubjectsETCO monitor will be used to measure CO levels in subjects and controls. | Device | End-tidal Carbon Monoxide Subjects |
| End-tidal Carbon Monoxide ControlsETCO monitor will be used to measure CO levels in subjects and controls. | Device | End-tidal Carbon Monoxide Controls |
Primary outcome
End-Tidal Carbon Monoxide
Time frame: 1 hour
Compare ETCO between subjects and controls
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25683629Lal A, Patterson L, Goldrich A, Marsh A. Point-of-care end-tidal carbon monoxide reflects severity of hemolysis in sickle cell anemia. Pediatr Blood Cancer. 2015 May;62(5):912-4. doi: 10.1002/pbc.25447. Epub 2015 Feb 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashutosh Lal, MD principal investigator
Children's Hospital & Research Center at Oakland
Questions about this trial
What is this clinical trial studying?
A study testing End-tidal Carbon Monoxide Subjects in people with Sickle Cell Anemia, run by UCSF Benioff Children's Hospital Oakland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-Tidal Carbon Monoxide (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.