Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases (COOX)

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

Study Overview

• Status: Completed
• Conditions: Pneumonia; Asthma; Allergic Rhinitis; Cystic Fibrosis

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.

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 24 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Jonathan Gaffin, MD. MMSc., Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (ESTIMATE): July 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Asthma; Pneumonia; Cystic fibrosis; Allergic rhinitis; Rhinitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Pancreatic Diseases; Fibrosis; Lung Diseases; Pneumonia; Rhinitis; Rhinitis, Allergic; Cystic Fibrosis
• Other Study ID Numbers: ChildrenH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO