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

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ClinicalTrials.gov Identifier: NCT02831348
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan M. Gaffin, Boston Children’s Hospital

Tracking Information
First Submitted Date July 11, 2016
First Posted Date July 13, 2016
Last Update Posted Date March 27, 2018
Actual Study Start Date October 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2016)
SpCO comparison: uncontrolled asthma v. other groups [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02831348 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases
Official Title Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Asthma
  • Allergic Rhinitis
  • Cystic Fibrosis
  • Pneumonia
Intervention Not Provided
Study Groups/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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 11, 2016)
84
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jonathan M Gaffin, MD, MMSc 857-218-5379 ext 4768 jonathan.gaffin@childrens.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02831348
Other Study ID Numbers ChildrenH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jonathan M. Gaffin, Boston Children’s Hospital
Study Sponsor Boston Children’s Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Boston Children’s Hospital
Verification Date March 2018