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

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

Tracking Information

• First Submitted Date: August 19, 2015
• First Posted Date: August 21, 2015
• Results First Submitted Date: September 23, 2020
• Results First Posted Date: October 19, 2020
• Last Update Posted Date: June 9, 2021
• Study Start Date: July 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2015)

End-Tidal Carbon Monoxide [ Time Frame: 1 hour ]

Compare ETCO between subjects and controls

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Carbon Monoxide Measurement to Screen for Sickle Cell Disease
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Sickle Cell Anemia

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 23, 2020): 32
• Original Estimated Enrollment (submitted: August 19, 2015): 20
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02530242
• Other Study ID Numbers: 2015-013
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: UCSF Benioff Children's Hospital Oakland
• Original Responsible Party: Same as current
• Current Study Sponsor: UCSF Benioff Children's Hospital Oakland
• Original Study Sponsor: Same as current
• Collaborators: Capnia, Inc.

Investigators

• Principal Investigator: Ashutosh Lal, MD; Children's Hospital & Research Center at Oakland

• PRS Account: UCSF Benioff Children's Hospital Oakland
• Verification Date: May 2021