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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848691
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Ashutosh Lal, UCSF Benioff Children's Hospital Oakland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Other: Measurement of carbon monoxide level in exhaled breath Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. End-Tidal Carbon Monoxide Concentration [ Time Frame: one year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
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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): NCT01848691


Locations
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United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Ashutosh Lal
Investigators
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Principal Investigator: Ashutosh Lal, MD Children's Hospital & Research Center at Oakland
More Information
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Responsible Party: Ashutosh Lal, Associate Hematologist/Oncologist, UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT01848691    
Other Study ID Numbers: Capnia CoSense Award 12.8062
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Hemolysis
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
 Pathologic Processes
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs