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Carbon Monoxide Measurement to Screen for Sickle Cell Disease (SCDCO)

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ClinicalTrials.gov Identifier: NCT02530242
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Capnia, Inc.
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Tracking Information
First Submitted Date  ICMJE August 19, 2015
First Posted Date  ICMJE August 21, 2015
Results First Submitted Date  ICMJE September 23, 2020
Results First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Study Start Date  ICMJE July 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
End-Tidal Carbon Monoxide [ Time Frame: 1 hour ]
Compare ETCO between subjects and controls
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbon Monoxide Measurement to Screen for Sickle Cell Disease
Official Title  ICMJE Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Sickle Cell Anemia
Intervention  ICMJE
  • Device: End-tidal Carbon Monoxide Subjects
    ETCO monitor will be used to measure CO levels in subjects and controls.
  • Device: End-tidal Carbon Monoxide Controls
    ETCO monitor will be used to measure CO levels in subjects and controls.
Study Arms  ICMJE
  • End-tidal Carbon Monoxide Subjects
    Children between 1-18 years old with Sickle Cell Anemia
    Intervention: Device: End-tidal Carbon Monoxide Subjects
  • End-tidal Carbon Monoxide Controls
    Healthy children age matched with subjects.
    Intervention: Device: End-tidal Carbon Monoxide Controls
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2020)
32
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2015)
20
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02530242
Other Study ID Numbers  ICMJE 2015-013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCSF Benioff Children's Hospital Oakland
Study Sponsor  ICMJE UCSF Benioff Children's Hospital Oakland
Collaborators  ICMJE Capnia, Inc.
Investigators  ICMJE
Principal Investigator: Ashutosh Lal, MD Children's Hospital & Research Center at Oakland
PRS Account UCSF Benioff Children's Hospital Oakland
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP