None listed
Conditions
Brief summary
The low utility of lung function testing in clinical practice, despite its importance, is not surprising as to date there are no randomised controlled trials (RCT) that have assessed the benefits in routine clinical practice. This RCT will assess the benefit of spirometry, in all paediatric respiratory conditions, which may lead to a change in routine clinical practice. If this study shows that spirometry has a positive impact on clinical decision making and quality of life, this evidence will encourage the use of spirometry as an important clinical assessment tool in both tertiary and primary care practice.
Interventions
The intervention is spirometry. Both the intervention and control groups will have spirometry with bronchodilator testing using the Queensland Children’s Hospital standard practice guide. This standard practice guide follows American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria for lung function testing in children (Miller MR, et al. Standardisation of spirometry. The European respiratory journal. 2005;26(2):319-38; Beydon N, et al. An official American Thoracic Society
The intervention is spirometry. Both the intervention and control groups will have spirometry with bronchodilator testing using the Queensland Children’s Hospital standard practice guide. This standard practice guide follows American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria for lung function testing in children (Miller MR, et al. Standardisation of spirometry. The European respiratory journal. 2005;26(2):319-38; Beydon N, et al. An official American Thoracic Society/European Respiratory Society statement: pulmonary function testing in preschool children. American journal of respiratory and critical care medicine. 2007;175(12):1304-45) In this standard guide each child performs at least 3 acceptable manoeuvres, including o Good start of forceful exhalation without hesitation or gradual onset o Smooth flow of spirograms without artefacts o At least 3 seconds of exhalation showing plateau of lung volume o At least 2 manoeuvres which have FVC and FEV1 repeatability, not more than 10% or 100 ml of difference These standards ensure acceptability, reproducibility and fidleity of the intervention. Further the spirometers are calibrated daily before use. The intervention will be one single session of 15-30 minutes for each participant enrolled in the study. All spirometry testing will be administered by experienced paediatric respiratory scientists in a tertiary hospital laboratory. The intervention group sees the doctor with the spirometry report. The control group sees the doctor without the spirometry report. The control group then sees the doctor again a second time with the spirometry report.
Sponsors
Dr Wicharn Boonjindasup
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
• A child with parents/guardians in attendance and able to provide written consent. • A child aged from 4 to 18 years, who can perform acceptable spirometry • Parent/guardian that is able to complete QoL questionnaires • A child whose physician is willing to being part of the LoCQ Study
Exclusion criteria
• Previously enrolled • Contraindication for spirometry including dyspnoea, pneumothorax, haemoptysis, vital signs instability, lung cyst or bleb, and recent chest/eye surgery (<3 weeks)
Outcome results
None listed