Improving the knowledge and utility of flexible bronchoscopy in children

INTERVENTION: 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) CONDITION: Paediatric respiratory disorders; ; Paediatric respiratory disorders Public Health ‐ Health service research Respiratory ‐ Asthma Respiratory ‐ Other respiratory disorders / diseases PRIMARY OUTCOME: Change in quality of life (assessed using Peds QL 4.0)[Change in PedsQL 4.0 scores at time point 2 ‐> ; 1) In the intervention group (early FB) ‐ 2 weeks after FB (assuming usual wait period is 5‐6 weeks); 2) In the control group (usual wait FB) ‐ 2 weeks prior to the usual wait for flexible bronchoscopy (assuming usual wait period is 5‐6 weeks); This is the primary timepoint.; ; Peds QL 4.0 will also be collected at two other time points for both groups; 1) 6 weeks post assumed usual wait FB period of 5‐6 weeks; 2) 6 months post recruitment] SECONDARY OUTCOME: Change in DASS21 scores [Time point 2 (2 weeks prior to the usual wait for flexible bronchoscopy) ‐‐> ; 1) In the intervention group (early FB) ‐ 2 weeks after FB (assuming usual wait period is 5‐6 weeks) ; 2) In the control group (usual wait FB) ‐ 2 weeks prior to the usual wait for flexible bronchoscopy (assuming usual wait period is 5‐6 weeks) ; This is the secondary timepoint [2]. ; ; DASS21 will also be collected at two other time points for both groups ; 1) 6 weeks post assumed usual wait FB period of 5‐6 weeks ; 2) 6 months post recruitment] If cough is part of presenting complaint, change in parent‐proxy children’s Acute Cough‐specific Quality of Life (PAC‐QoL)[Time point 2 (2 weeks prior to the usual wait for flexible bronchoscopy) ‐‐> ; 1) In the intervention group (early FB) ‐ 2 weeks after FB (assuming usual wait period is 5‐6 weeks) ; 2) In the control group (usual wait FB) ‐ 2 weeks prior to the usual wait for flexible bronchoscopy (assuming usual wait period is 5‐6 weeks) ; This is the secondary timepoint [3]. ; ; PAC‐QoL will also be collected at two other time points for both groups ; 1) 6 weeks post assumed usual wait FB period of 5‐6 weeks ; 2) 6 months post recruitment] Proportion of children whereby FB changes clinical management (this is one secondary outcome). For example: ; c. Change in type of IV or PO antibiotics after broncho‐alveolar (BAL) culture results are available ; ; [At the time of flexible bronchoscopy in both arms (usual wait is 5‐6 weeks, early group would be 2 weeks)] 2) <18 years of age 3) Agree to remain at the study site for >6 months ; a. Decision to admit for intravenous (IV) antibiotics and physiotherapy directly after FB. This will be based on the secretion score (Chang et al, Peds Pulm, 2006) and Bronkotest®, London, United Kingdom). ; b. Started oral (PO) antibiotics directly after FB (excluding azithromycin for computed tomography [CT] scan proven bronchiectasis [BE]). This will also be based on the secretion score (Chang et al, Peds Pulm, 2006) and Bronkotest®, London, United Kingdom). ; d. Referred to another specialty for appropriate major management changes for intervention based on findings on FB. Examples include referral to surgeons such as cardiothoracic (e.g. for vascular ring), ear, nose, throat (ENT) (eg. subglottic lesion), paediatric surgeon (e.g. tracheo‐oesophageal fistula). 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