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CompletedNCT02831348COOXUpdated Sep 22, 2022

Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases

An observational study in Asthma, Allergic Rhinitis and Cystic Fibrosis, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 6 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-22.

Sponsored by Boston Children's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
59
Ages
6 Years to 24 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Asthma
  • Allergic Rhinitis
  • Cystic Fibrosis
  • Pneumonia

Keywords

  • Asthma
  • Allergic rhinitis
  • Rhinitis
  • Pneumonia
  • Cystic fibrosis
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 59 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Age range 6-24years old. All genders, races, and ethnicities were sampled, provided they could complete the study requirements.

Inclusion criteria

  • diagnosis of asthma, pneumonia, allergic rhinitis, or none of the previous (control group)
  • Ability to complete study procedures

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
59 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

  • Controlled asthma

    Indicated by an ACT score of \>19, or spirometry results within 10% of year's best value (based on FEV1).

  • Pneumonia

    Indicated by an admission diagnosis of pneumonia with chest X-ray consistent with the diagnosis, based on attending radiologist's interpretation.

  • Controlled allergic rhinitis

    Indicated by a rhinitis control assessment test (RCAT) score of \>= 21.

  • Uncontrolled allergic rhinitis

    Indicated by an RCAT score of \<21.

  • Cystic fibrosis (exacerbated)

    Indicated by treating physician's assessment of cystic fibrosis respiratory exacerbation within 24 hours of initial antibiotic therapy.

  • 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.

  • Control

    Indicated by a negative history of any of the conditions characterizing the other groups.

06

What researchers measure

Primary outcomes

  1. 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 frame: Time of visit

07

Study locations

1 site
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02831348
Lead sponsor
Boston Children's Hospital
Responsible party
Jonathan M. Gaffin (Principal Investigator, Boston Children's Hospital) — Principal investigator
First posted
Jul 13, 2016
Start date
Oct 2015
Primary completion
Dec 2021
Completion
Dec 2021
Last update
Sep 22, 2022

Study contacts

Jonathan Gaffin, MD. MMSc.
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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