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

Primary Purpose

Sickle Cell Anemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
End-tidal Carbon Monoxide Subjects
End-tidal Carbon Monoxide Controls
Sponsored by
UCSF Benioff Children's Hospital Oakland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sickle Cell Anemia focused on measuring Sickle Cell Anemia

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    End-tidal Carbon Monoxide Subjects

    End-tidal Carbon Monoxide Controls

    Arm Description

    Children between 1-18 years old with Sickle Cell Anemia

    Healthy children age matched with subjects.

    Outcomes

    Primary Outcome Measures

    End-Tidal Carbon Monoxide
    Compare ETCO between subjects and controls

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2015
    Last Updated
    May 14, 2021
    Sponsor
    UCSF Benioff Children's Hospital Oakland
    Collaborators
    Capnia, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02530242
    Brief Title
    Carbon Monoxide Measurement to Screen for Sickle Cell Disease
    Acronym
    SCDCO
    Official Title
    Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UCSF Benioff Children's Hospital Oakland
    Collaborators
    Capnia, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sickle Cell Anemia
    Keywords
    Sickle Cell Anemia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    End-tidal Carbon Monoxide Subjects
    Arm Type
    Other
    Arm Description
    Children between 1-18 years old with Sickle Cell Anemia
    Arm Title
    End-tidal Carbon Monoxide Controls
    Arm Type
    Other
    Arm Description
    Healthy children age matched with subjects.
    Intervention Type
    Device
    Intervention Name(s)
    End-tidal Carbon Monoxide Subjects
    Intervention Description
    ETCO monitor will be used to measure CO levels in subjects and controls.
    Intervention Type
    Device
    Intervention Name(s)
    End-tidal Carbon Monoxide Controls
    Intervention Description
    ETCO monitor will be used to measure CO levels in subjects and controls.
    Primary Outcome Measure Information:
    Title
    End-Tidal Carbon Monoxide
    Description
    Compare ETCO between subjects and controls
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashutosh Lal, MD
    Organizational Affiliation
    Children's Hospital & Research Center at Oakland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25683629
    Citation
    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.
    Results Reference
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