Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases

NCT ID: NCT02831348

Last Updated: 2022-09-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma Allergic Rhinitis Cystic Fibrosis Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jonathan M. Gaffin

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

Other Identifiers

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ChildrenH

Identifier Type: -

Identifier Source: org_study_id

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