None listed
Conditions
Brief summary
FB is primarily used in children for diagnostic purposes and sometimes is also therapeutic. It involves viewing airways with a flexible instrument, and obtaining lower airway specimens. FB is commonly used in paediatric respiratory centres around the world to help in diagnosis and to help guide management in patients with respiratory complaints like chronic cough, recurrent croup and recurrent wheeze. Publications on indications, contraindications and complications of FB are based on expert opinion and retrospective studies. Indeed, two international thoracic societies (American Thoracic Society and European Respiratory Society) highlighted the paucity of prospective studies and absence of any RCTs. This is a critical gap, as FBs are undertaken using general anaesthesia. There are risks associated with general anaesthesia in addition to those from FB itself (e.g. hypoxia, nausea, vomiting, headaches, confusion and unscheduled hospitalisation). There are also cost implications to the health system and the family. Thus, it is not surprising that different centres have varying approaches resulting in vast differences in the number of FBs undertaken. At Queensland Children’s Hospital, Brisbane, ~550 FBs/year are undertaken but other Australian paediatric centres carry out less than half of this number. Thus, a RCT is required to define the efficacy and benefits to address this gap. Our study’s goal is to examine the impact of FB on quality of life (patient reported outcome) and change in management in children under the rigour of an RCT with the hypothesis that paediatric FB leads to improvement in quality of life and to change in managment. Ultimately, this will clarify the utility of FB in children and will improve clinical outcomes for children.
Interventions
Flexible bronchoscopy (FB) is the main intervention. This is a parallel single-centre, single-blind, randomised control trial (RCT) with a superiority hypothesis. The current waiting time for a FB at the location of this RCT is approximately 5-6 weeks. Children in the intervention group (early arm) will have FB within 1-2 weeks of enrolment. The flexible bronchoscopy is undertaken under general anaesthetic at the institution this study will occur. It is performed by respiratory physicians and trainees and involves a flexible bronchoscope passed through the nasal passage into the larynx and tracheobronchial tree (down to the segmental and subsegmental bronchi). The FB itself takes about 10 to 15 minutes but the whole procedure may take up to 30 minutes (including time for general anaesthetic to take effect). For patients of both control and treatment arms, FB will be performed but at different time-points as aforementioned. The researcher will be present during all FB procedures and evaluate for presence of bronchitis (secretion score and Bronkotest)
Sponsors
Study design
Eligibility
Inclusion criteria
1) Children referred to the paediatric respiratory outpatient clinic of Queensland Children's Hospital in Brisbane who require a flexible bronchoscopy (FB) as deemed by the child’s primary respiratory physician as part of the routine clinical investigation pathway 2) <18 years of age 3) Agree to remain at the study site for >6 months
Exclusion criteria
1) Urgent FB required (e.g. examination of severe stridor) 2) Previously enrolled 3) Previous FB 4) No informed consent 5) Limited English literacy skills