Carbon Monoxide Measurement to Screen for Sickle Cell Disease

NCT02530242 | Completed Results

• 1 other identifier: 2015-013
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Sickle Cell Anemia

Keywords

Sickle Cell Anemia

Outcome Measures

Primary Outcomes (1)

• End-Tidal Carbon Monoxide

  Compare ETCO between subjects and controls

  1 hour

Study Arms (2)

End-tidal Carbon Monoxide Subjects

OTHER

Children between 1-18 years old with Sickle Cell Anemia

Device: End-tidal Carbon Monoxide Subjects

End-tidal Carbon Monoxide Controls

OTHER

Healthy children age matched with subjects.

Device: End-tidal Carbon Monoxide Controls

Interventions

End-tidal Carbon Monoxide Subjects DEVICE

ETCO monitor will be used to measure CO levels in subjects and controls.

End-tidal Carbon Monoxide Subjects

End-tidal Carbon Monoxide Controls DEVICE

ETCO monitor will be used to measure CO levels in subjects and controls.

End-tidal Carbon Monoxide Controls

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• Capnia, Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 25683629 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

A limitation of the data is the small number of subjects and that it was conducted under controlled circumstances in the clinic.

Results Point of Contact

• Title: Ashutosh Lal, MD
• Organization: UCSF Benioff's Children's Hospital Oakland

Ashutosh.Lal@ucsf.edu

Study Officials

• Ashutosh Lal, MD

  Children's Hospital & Research Center at Oakland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 21, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 9, 2021
• Results First Posted: October 19, 2020

Record last verified: 2021-05