Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000015448
Ethics application status
Approved
Date submitted
14/12/2015
Date registered
12/01/2016
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can ultrasound scanning be utilised in the assessment of paediatric airway pathology? A pilot study
Scientific title
Can ultrasound scanning be utilised in the assessment of paediatric airway pathology? A pilot study
Secondary ID [1] 288145 0
None
Universal Trial Number (UTN)
U1111-1170-2902
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subglottic / Tracheal abnormalities 297057 0
Condition category
Condition code
Respiratory 297284 297284 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An ultrasound of the neck will be performed by the trial Radiologists. This will involve a small probe being placed on the skin of the front of the neck. It will take approximately 15 minutes to complete the examination.All measurements will be performed by the examining Radiologist and repeated by a second to assess reproducibility of this method.

This examination will be performed as an additional study to the standard diagnostic laryngobronchoscopy in the 'study subjects'. It will be an additional examination undergoing imaging for other reasons in our 'normal subjects'.
Intervention code [1] 293458 0
Diagnosis / Prognosis
Comparator / control treatment
Patients presenting to the clinic with noisy breathing will undergo standard Otorhinolaryngology (ORL) surgical assessment using diagnostic laryngobronchoscopy under sedation / general anaesthetic. This involes the ORL surgeon placing an endoscope within the airway to directly visualise the structures and assess for pathology. Only the 'study subjects' will undergo this assessment.
Control group
Active

Outcomes
Primary outcome [1] 296864 0
To determine whether ultrasound can detect subglottic and tracheal abnormalities. The findings from both the standard ORL assessment and the ultrasound will be reviewed by the surgeon and the radiologists to assess whether there is corellation between the two examinations.
Timepoint [1] 296864 0
When 100 'normal subjects' and 20 'study subjects' have undergone ultrasound assessment.
Secondary outcome [1] 319551 0
Reproducibility of standard measurements.
Images will be saved from the ultrasound assessment of 'normal subjects' and the standard measurements will be performed by at least two radiologists blinded to the results of previous attempts to assess whether this test is reproducible.
Timepoint [1] 319551 0
Within one week of the 'normal subjects' ultrasound examination.

Eligibility
Key inclusion criteria
1. any patient aged 0-12 years with symptoms suggestive of upper airway pathology at the level of the subglottis or below,
2. who is undergoing investigation with diagnostic laryngobronchoscopy
3. Normal subjects – any patient aged 0-12 years who is undergoing ultrasound imaging for other medical reasons.

Criteria 1 and 2 only apply to the 'study subjects' group.
Minimum age
No limit
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any patient presenting with an acute airway whose care would be compromised by enrolment in the study
2. Any patient presenting with symptoms suggestive of an inhaled foreign body
3. Any patient unable to complete a full preoperative airway ultrasound
4. Any patient with a medical condition known to be associated with airway pathology (eg Down Syndrome)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Will not be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Will not be blinded.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/01/2016
Actual
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 7419 0
New Zealand
State/province [1] 7419 0

Funding & Sponsors
Funding source category [1] 292554 0
Government body
Name [1] 292554 0
Capital and Coast District Health Board
Country [1] 292554 0
New Zealand
Primary sponsor type
Government body
Name
Capital and Coast District Health Board
Address
Wellington Regional Hospital
Riddiford Street
Wellington
6021
Country
New Zealand
Secondary sponsor category [1] 291273 0
None
Name [1] 291273 0
N/A
Address [1] 291273 0
N/A
Country [1] 291273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294032 0
Health and Disability Ethics Committee
Ethics committee address [1] 294032 0
Ministry of Health,
Ethics Department,
Freyberg Building,
20 Aitken Street,
Wellington.
6011.
Ethics committee country [1] 294032 0
New Zealand
Date submitted for ethics approval [1] 294032 0
09/10/2015
Approval date [1] 294032 0
09/12/2015
Ethics approval number [1] 294032 0
15/NTB/198

Summary
Brief summary
The objective of this clinical trial is to determine the utility of ultrasound scanning in assessing paediatric patients presenting with symptoms of airway pathology at the level of the subglottis or trachea. Age matched patients who have no airway symptoms but are presenting for ultrasound imaging for other reasons will be the control subjects for this study. We hypothesise that ultrasound will be a good alternative tool for assessment obviating the need for more invasive examinations currently available.
This pilot study will prospectively acquire data over a 12 month period. We anticipate that 100 normal subjects and 20 study subjects will be recruited over this period.





Duration of Study
The pilot study will run for 12 month duration
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 62194 0
Dr Jean Murdoch
Address 62194 0
Radiology Department
Wellington Regional Hospital
Riddiford Street
Wellington
6021
Country 62194 0
New Zealand
Phone 62194 0
+6443855999
Fax 62194 0
Email 62194 0
[email protected]
Contact person for public queries
Name 62195 0
Dr Jean Murdoch
Address 62195 0
Radiology Department
Wellington Regional Hospital
Riddiford Street
Wellington
6021
Country 62195 0
New Zealand
Phone 62195 0
+6443855999
Fax 62195 0
Email 62195 0
[email protected]
Contact person for scientific queries
Name 62196 0
Dr Jean Murdoch
Address 62196 0
Radiology Department
Wellington Regional Hospital
Riddiford Street
Wellington
6021
Country 62196 0
New Zealand
Phone 62196 0
+6443855999
Fax 62196 0
Email 62196 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.