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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 : June 9, 2021
Sponsor:
Collaborator:
Capnia, Inc.
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Study Description
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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).

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Device: End-tidal Carbon Monoxide Subjects Device: End-tidal Carbon Monoxide Controls Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
End-tidal Carbon Monoxide Subjects
Children between 1-18 years old with Sickle Cell Anemia
 Device: 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 matched with subjects.
 Device: End-tidal Carbon Monoxide Controls
ETCO monitor will be used to measure CO levels in subjects and controls.


Outcome Measures
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Primary Outcome Measures :
  1. End-Tidal Carbon Monoxide [ Time Frame: 1 hour ]
    Compare ETCO between subjects and controls


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530242


Sponsors and Collaborators
UCSF Benioff Children's Hospital Oakland
Capnia, Inc.
Investigators
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Principal Investigator: Ashutosh Lal, MD Children's Hospital & Research Center at Oakland
More Information
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Publications:

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Responsible Party: UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT02530242    
Other Study ID Numbers: 2015-013
First Posted: August 21, 2015    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: June 9, 2021
Last Verified: May 2021
Keywords provided by UCSF Benioff Children's Hospital Oakland:
Sickle Cell Anemia
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
 Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs