Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02831348

Acronym

COOX

Enrollment

Registered

2016-07-13

Start date

2015-10-31

Completion date

2021-12-31

Last updated

2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Asthma, Cystic Fibrosis, Pneumonia

Keywords

Asthma, Allergic rhinitis, Rhinitis, Pneumonia, Cystic fibrosis

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Years to 24 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
SpCO comparison: uncontrolled asthma v. other groups	Time of visit	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.

Countries

United States

Outcome results