Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis

NCT01848691 | Completed

• 1 other identifier: Capnia CoSense Award 12.8062
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

People who have Sickle Cell Anemia (HbSS) produce red blood cells with shorter lifespans. These red blood cells breakdown faster, and this is called hemolysis. When red blood cells breakdown, a tiny amount of Carbon Monoxide (CO) is released into the blood and is eliminated in exhaled breath. This research study will use a device called CoSense™, which will measure Carbon Monoxide (CO) levels in breath. The purpose of the study is to see how well the device measures the CO levels that an individual breathes out.

Conditions

Sickle Cell Anemia

Outcome Measures

Primary Outcomes (1)

• End-Tidal Carbon Monoxide Concentration

  one year

Study Arms (2)

Sickle Cell

EXPERIMENTAL

This arm will include 20 children with sickle cell anemia

Other: Measurement of carbon monoxide level in exhaled breath

Control

ACTIVE COMPARATOR

This arm will include 20 children without sickle cell anemia

Other: Measurement of carbon monoxide level in exhaled breath

Interventions

Measurement of carbon monoxide level in exhaled breath OTHER

Measurement of end-tidal carbon monoxide concentration

Also known as: CoSense Carbon Monoxide Monitor

Control; Sickle Cell

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parental / legal guardian consent
• Subject assent for participants ages 7 and above
• Male and female children ages 5 - 14 years old
• For Hb SS subjects, hemoglobin ≤ 10 g/dL (based on a laboratory tests performed over the last 6 months and confirmed within 4 weeks prior to breath collection, as part of the subject's clinical care)

You may not qualify if:

• For healthy subjects, known to have the sickle cell trait
• Had a red blood cell transfusion within 12 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 an upper respiratory infection within 2 weeks of ETCO measurements

Sponsors & Collaborators

• Ashutosh Lal: lead

Study Sites (1)

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

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

Study Officials

• Ashutosh Lal, MD

  Children's Hospital & Research Center at Oakland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Hematologist/Oncologist

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 7, 2013
• Study Start: October 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

US (1)