Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases
NCT ID: NCT02831348
Last Updated: 2022-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
59 participants
OBSERVATIONAL
2015-10-31
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Uncontrolled asthma
Indicated by an asthma control test (ACT) score of \<20 and asthma symptoms of cough, wheeze, or chest tightness for more than 2 days in the prior 2 weeks, OR current asthma exacerbation indicated by the prescription of a short course (3-5 days) of systemic corticosteroids by treating provider at the time of visit.
No interventions assigned to this group
Controlled asthma
Indicated by an ACT score of \>19, or spirometry results within 10% of year's best value (based on FEV1).
No interventions assigned to this group
Pneumonia
Indicated by an admission diagnosis of pneumonia with chest X-ray consistent with the diagnosis, based on attending radiologist's interpretation.
No interventions assigned to this group
Controlled allergic rhinitis
Indicated by a rhinitis control assessment test (RCAT) score of \>= 21.
No interventions assigned to this group
Uncontrolled allergic rhinitis
Indicated by an RCAT score of \<21.
No interventions assigned to this group
Cystic fibrosis (exacerbated)
Indicated by treating physician's assessment of cystic fibrosis respiratory exacerbation within 24 hours of initial antibiotic therapy.
No interventions assigned to this group
Cystic fibrosis (stable)
Indicated by diagnosis of cystic fibrosis with baseline symptoms and with spirometry results (based on FEV1) within 5% of year's best value.
No interventions assigned to this group
Control
Indicated by a negative history of any of the conditions characterizing the other groups.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Ability to complete study procedures
Exclusion Criteria
* 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.
6 Years
24 Years
ALL
Yes
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Jonathan M. Gaffin
Principal Investigator
Principal Investigators
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Jonathan Gaffin, MD. MMSc.
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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ChildrenH
Identifier Type: -
Identifier Source: org_study_id
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