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

May 14, 2021 updated by: UCSF Benioff Children's Hospital Oakland

Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: End-tidal Carbon Monoxide Subjects
Children between 1-18 years old with Sickle Cell Anemia
Device: End-tidal Carbon Monoxide Subjects
ETCO monitor will be used to measure CO levels in subjects and controls.
Other: End-tidal Carbon Monoxide Controls
Healthy children age matched with subjects.
Device: End-tidal Carbon Monoxide Controls
ETCO monitor will be used to measure CO levels in subjects and controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End-Tidal Carbon Monoxide
Time Frame: 1 hour
Compare ETCO between subjects and controls
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCSF Benioff Children's Hospital Oakland

Collaborators

Capnia, Inc.

Investigators

  • Principal Investigator: Ashutosh Lal, MD, Children'S Hospital & Research Center At Oakland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 19, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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