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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ashutosh Lal, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01848691
First received: May 3, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Sickle Cell Anemia
Other: Measurement of carbon monoxide level in exhaled breath

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase 1 Study of Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • End-Tidal Carbon Monoxide Concentration [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sickle Cell
This arm will include 20 children with sickle cell anemia
Other: Measurement of carbon monoxide level in exhaled breath
Measurement of end-tidal carbon monoxide concentration
Other Name: CoSense Carbon Monoxide Monitor
Active Comparator: Control
This arm will include 20 children without sickle cell anemia
Other: Measurement of carbon monoxide level in exhaled breath
Measurement of end-tidal carbon monoxide concentration
Other Name: CoSense Carbon Monoxide Monitor

Detailed Description:

Subjects diagnosed with homozygous sickle cell anemia (Hb SS) have red blood cells with a decreased lifespan, which leads to an increase in the rate of heme turnover. Carbon monoxide (CO) is a by-product of heme oxidation and is excreted in exhaled breath. The concentration of CO in end-tidal breath can be measured and used to indicate the rate of heme oxidation, bilirubin production and the presence of hemolysis. The objective of this study is to characterize the performance of CoSense™ in children with or without sickle cell anemia. This is a single-center, open-label, non-randomized, proof of concept study to characterize the ability of CoSense™ to assess ETCO levels in subjects with a diagnosis of sickle cell anemia (Hb SS). Up to 40 children (5-14 years old), of which 20 participants will have a diagnosis of Hb SS, will be enrolled. Each participant will have two breath samples collected non-invasively, one immediately after the other. It takes approximately 120 seconds to collect the each breath sample. This study and investigational device are a non-significant risk to the patient. The nasal cannula is made of a biocompatibility-tested polyvinyl chloride (PVC) material with a soft open-end, and will be gently placed adjacent to one of the nostrils and partially inserted by approximately 5 mm. The objective of this study will be assessed through reproducibility of ETCO measurements and comparison of ETCO levels between children diagnosed with Hb SS and healthy children. The study would help in the development of a portable CO measurement device which has potential health applications in monitoring diseases with altered bilirubin metabolism.

  Eligibility

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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     
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848691

Locations
United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Ashutosh Lal
Investigators
Principal Investigator: Ashutosh Lal, MD Children's Hospital & Research Center at Oakland
  More Information

No publications provided

Responsible Party: Ashutosh Lal, Associate Hematologist/Oncologist, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01848691     History of Changes
Other Study ID Numbers: Capnia CoSense Award 12.8062
Study First Received: May 3, 2013
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carbon Monoxide
Anemia, Sickle Cell
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Antimetabolites
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014