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Trial registered on ANZCTR


Registration number
ACTRN12620000610932
Ethics application status
Approved
Date submitted
30/04/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the knowledge and utility of flexible bronchoscopy in children
Scientific title
Improving the knowledge and utility of flexible bronchoscopy (FB) in children: a parallel single-centre, single-blind, randomised controlled trial (RCT)
Secondary ID [1] 301107 0
None
Universal Trial Number (UTN)
Trial acronym
BURT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric respiratory disorders 317287 0
Condition category
Condition code
Respiratory 315406 315406 0 0
Other respiratory disorders / diseases
Respiratory 315408 315408 0 0
Asthma
Public Health 315409 315409 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 317469 0
Diagnosis / Prognosis
Comparator / control treatment
Children in the control group (i.e. normal wait) will have their flexible bronchoscopy (FB) as currently routinely done.
Control group
Active

Outcomes
Primary outcome [1] 323658 0
Change in quality of life (assessed using Peds QL 4.0)
Timepoint [1] 323658 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 [1] 382512 0
Proportion of children whereby FB changes clinical management (this is one secondary outcome). For example:
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).
c. Change in type of IV or PO antibiotics after broncho-alveolar (BAL) culture results are available
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).

Timepoint [1] 382512 0
At the time of flexible bronchoscopy in both arms (usual wait is ~5-6 weeks, early group would be 2 weeks)
Secondary outcome [2] 382513 0
Change in DASS21 scores
Timepoint [2] 382513 0
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
Secondary outcome [3] 382514 0
If cough is part of presenting complaint, change in parent-proxy children’s Acute Cough-specific Quality of Life (PAC-QoL)
Timepoint [3] 382514 0
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

Eligibility
Key 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
Minimum age
0 Days
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After informed consent, children will be allocated to one of the 2 arms in concealed manner (opaque envelope system) in the appropriate stratified list
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The codes (in the envelope) will be undertaken by an independent person using computer-generated randomisation (permutated blocks of 4-6) and stratified by (a) indication for FB (chronic cough or other indication); and (b) age (= or > 2 yrs).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 305552 0
Hospital
Name [1] 305552 0
Queensland Children's Hospital
Address [1] 305552 0
Respiratory and Sleep Department
Queensland Children’s Hospital
501 Stanley St
South Brisbane
QLD 4101
Country [1] 305552 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
501 Stanley St
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 305958 0
University
Name [1] 305958 0
Queensland University of Technology
Address [1] 305958 0
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, QLD 4101
Country [1] 305958 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305859 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 305859 0
Level 7, Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 305859 0
Australia
Date submitted for ethics approval [1] 305859 0
Approval date [1] 305859 0
16/04/2020
Ethics approval number [1] 305859 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101834 0
Dr Rahul Thomas
Address 101834 0
Queensland Children’s Hospital
501 Stanley St
South Brisbane
QLD 4101
Country 101834 0
Australia
Phone 101834 0
+61 7 30682300
Fax 101834 0
Email 101834 0
rahul.thomas@health.qld.gov.au
Contact person for public queries
Name 101835 0
Dr Rahul Thomas
Address 101835 0
Queensland Children’s Hospital
501 Stanley St
South Brisbane
QLD 4101
Country 101835 0
Australia
Phone 101835 0
+61 7 30682300
Fax 101835 0
Email 101835 0
rahul.thomas@health.qld.gov.au
Contact person for scientific queries
Name 101836 0
Dr Rahul Thomas
Address 101836 0
Queensland Children’s Hospital
501 Stanley St
South Brisbane
QLD 4101
Country 101836 0
Australia
Phone 101836 0
+61 7 30682300
Fax 101836 0
Email 101836 0
rahul.thomas@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results