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NCT02831348 Clinical Trial

Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases

Asthma Clinical Trial

— COOX  

Official title:
Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02831348
Other study ID # ChildrenH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2015
Est. completion date December 2021

Study information
Verified date September 2022
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children with inflammatory and non-inflammatory conditions.

Description:

Children and young adults age 6-24 with the following conditions: asthma, pneumonia, allergic rhinitis, cystic fibrosis, and well child (without inflammatory illness) will be recruited. Subjects will be asked to complete a brief screening survey to determine if they meet inclusion criteria. Enrolled subjects will be asked to complete questionnaire forms to characterize their health, current symptoms, medications, and common exposures. Transcutaneous carboxyhemoglobin will be recorded. This study is cross-sectional and will only require one visit coinciding with the clinical visit. Analysis will determine the pairwise differences in SpCO between conditions tested.

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 24 Years
Eligibility Inclusion Criteria: - diagnosis of asthma, pneumonia, allergic rhinitis, or none of the previous (control group) - Ability to complete study procedures Exclusion Criteria: - Cardiopulmonary disease outside of the specific conditions for inclusion - Prematurity - Congenital heart disease - Current diagnosis of more than one of the following: asthma, pneumonia, allergic rhinitis, cystic fibrosis, or - for controls - any current infection - Recent serious bacterial infection (except for pneumonia in the pneumonia group) - Concurrent clinical chest X-ray with findings other those that expected for the group (i.e. normal chest X-ray in pneumonia group or suspected pneumonia on chest X-ray in asthma group). To be determined by attending radiologist's interpretation.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary SpCO comparison: uncontrolled asthma v. other groups A pairwise comparison of mean SpCO will be performed between asthma exacerbation group and each other group, e.g., asthma exacerbation v. stable asthma, asthma exacerbation v. pneumonia, etc. An independent t-test will be used to determine statistical significance of the difference of means. Time of visit
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