Physiology Assessment by Bedside Ultrasonography in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Louisville
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT02004938
First received: August 19, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

Project Aims: The primary aim is to establish normal ultrasound parameters in healthy children for internal jugular collapse during respiration. The secondary aim is to explore potential ultrasound parameters which could be used as surrogate markers for pulmonary function in the management of children with acute asthma.

Hypothesis: Ultrasound measurements of internal jugular vein collapse of children can be reliably measured. Children experiencing an asthma exacerbation will have significantly different measurements than of the same age who are healthy. In addition, ultrasound measurements of the lung and vasculature will correlate with pulmonary function testing and asthma clinical scoring.

Intervention: For patients in the normal respiratory physiology (NRP) group, medications and past medical history will be recorded, along with documentation that the patient has not had any recent respiratory symptoms or fever. For the acute asthmatics (AA) group, history of present illness, underlying asthma severity, asthma-related treatment including admission/discharge from ED, medications, and past medical history will be recorded.

Spirometry readings will be collected on all patients. In addition, a clinical asthma score will be assigned using the Modified Woods pulmonary index scoring system.

Using bedside ultrasonography with the Sonosite Titan ultrasound machine, each measurement will be taken with the subject lying in bed with the head of the bed elevated at 45 degrees with the subject's head in the neutral position. Initially, measurements of the internal jugular vein at maximal inhalation and exhalation will be recorded, and the difference between the two will be calculated.


Condition Intervention
Asthma
Device: Sonosite Titan Ultrasound Machine
Device: EasyOne Spirometer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primary Physiology Assessment by Bedside Ultrasonography in Children

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Measurement of diameter of right internal jugular vein at maximum inhalation and exhalation [ Time Frame: During ED stay at initiation of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of FVC, FEV1/FVC [ Time Frame: During ED stay at initiation of intervention ] [ Designated as safety issue: No ]
  • Clinical Asthma Score [ Time Frame: During ED stay at initiation of intervention ] [ Designated as safety issue: No ]
    Will be recorded using Modified Woods pulmonary index scoring system.

  • Measurement of level of dehydration [ Time Frame: During ED stay ] [ Designated as safety issue: No ]
    Will measure using the Gorelick scale.


Estimated Enrollment: 80
Study Start Date: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
normal respiratory function
Those subjects with normal respiratory function
Device: Sonosite Titan Ultrasound Machine Device: EasyOne Spirometer
asthma exacerbation
Those subjects being treated for acute asthma exacerbation
Device: Sonosite Titan Ultrasound Machine Device: EasyOne Spirometer

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

pediatric emergency department

Criteria

Inclusion Criteria:

Aged 6-17 years old presenting to the emergency department (ED) will be enrolled into the normal respiratory function group into the age quartiles (6-8 years, 9-11 years, 12-14 years and 15-17 years). The 40 subjects enrolled into the acute exacerbation group will have a previous physician diagnosis of asthma per parent report and an acute asthma exacerbation requiring corticosteroids per ED attending physician or fellow.

Exclusion Criteria:

Children in the normal respiratory function group will be excluded from participation if they have: a baseline chronic lung disorder (including asthma), current respiratory illness, fever, Emergency Services Index (ESI) triage category of less than or equal to 3 (high acuity), chronic cough, dyspnea with exercise, wheezing, or a history of smoking by self and/or parent report.

Children in the acute exacerbation group will be excluded from enrollment if they have a history of baseline chronic lung disease, not including asthma. In addition, a co-existing acute pulmonary process (e.g. lobar pneumonia), and impending respiratory failure will exclude from participation. Those who are unable to perform spirometry measurements per spirometry measuring protocol (see Appendix: Figure 1) will be excluded from participation.

Subjects will be excluded from either of the groups if they had prior cardiac/pulmonary disease or surgeries (other than asthma for the acute exacerbation group), significant musculoskeletal abnormalities (such as scoliosis) that might compromise baseline pulmonary function testing, a history of smoking tobacco or marijuana, and prematurity (birth at less than 37 weeks gestation. In addition, those with an allergy to ultrasound gel will be excluded from participation.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02004938

Contacts
Contact: Adam M Isacoff, MD 502-629-7212 amisac01@louisville.edu

Locations
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Adam Isacoff, MD         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Michelle D Stevenson, MD, MS University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT02004938     History of Changes
Other Study ID Numbers: IRB 13.0345
Study First Received: August 19, 2013
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
asthma
acute asthma exacerbation
asthma exacerbation
pediatric
respiratory

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014