Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001592235
Ethics application status
Approved
Date submitted
31/08/2018
Date registered
25/09/2018
Date last updated
25/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of handheld point of care ultrasonography to standard portable ultrasonography for identifying an optimal site for pleurocentesis in patients with pleural effusions
Scientific title
A comparison of handheld point of care ultrasonography to standard portable ultrasonography for identifying an optimal site for pleurocentesis in patients with pleural effusions
Secondary ID [1] 295951 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pleural effusion 309457 0
Condition category
Condition code
Respiratory 308295 308295 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will examine whether a highly portable handheld ultrasound would be able to determine a safe site with a standard point of care ultrasound used as the gold standard for diagnostic pleurocentesis. In this study, we will perform paired ultrasound assessments of patients with pleural effusions who are referred for diagnostic pleurocentesis. The intervention involves the patient undergoing two ultrasound assessments by a respiratory fellow and respiratory physician. The handheld ultrasound assessment is performed prior to the standard ultrasound assessment and takes approximately 5 to 10 minutes. This involves ultrasound gel on the side of the chest and the probe placed on the chest of the patient. A second assessor then performs the same ultrasound assessment with the standard ultrasound machine which also takes 5 to 10 minutes with the participant seated in the same location. Treatment will not be changed by the handheld ultrasound as the standard ultrasound will be used as the gold standard. The respiratory fellow and respiratory physician will be alternately allocated to either the handheld ultrasound or standard ultrasound machine.
Intervention code [1] 312277 0
Diagnosis / Prognosis
Comparator / control treatment
Standard point of care ultrasound is the current gold standard for the assessment of a pleural effusion prior to diagnostic pleurocentesis and is recommended by the Thoracic Society of Australia and New Zealand along with the British Thoracic Society and American Thoracic Society. The standard point of care ultrasound assessment involves an ultrasound scan of the chest wall to identify key structures and assess the size of the pleural effusion and underlying anatomy prior to the insertion of a needle into the chest cavity.
Control group
Active

Outcomes
Primary outcome [1] 307268 0
Safety of the needle insertion site identified by the handheld ultrasound as assessed by the findings from the standard ultrasound assessment based on the depth of pleural fluid, distance (in centimeters) from solid organs and diaphragm and distance from the skin to pleural surface.
Timepoint [1] 307268 0
Immediately following standard ultrasound assessment
Secondary outcome [1] 351314 0
Procedural outcome of the diagnostic pleurocentesis procedure (pleural fluid obtained or not)
Timepoint [1] 351314 0
Within 10 minutes following pleurocentesis
Secondary outcome [2] 351535 0
We will evaluate the differences in live image quality ratings from both devices in three domains (image resolution, image detail and total image quality) as assessed by a 5 point Likert rating scale
Timepoint [2] 351535 0
At the time of ultrasound assessment
Secondary outcome [3] 351540 0
We will assess still image quality of both devices in three domains (image resolution, image detail and total image quality) as assessed by a 5 point Likert rating scale
Timepoint [3] 351540 0
Performed by assessors using data collected during the initial ultrasound assessment (the rating will be performed within a 2 month period after the initial assessment)
Secondary outcome [4] 351546 0
We will assess inter-rater reliability of image quality scores of both devices using a 5 point Likert rating scale of still images.
Timepoint [4] 351546 0
Performed by assessors using data collected during the initial ultrasound assessment (the rating will be performed within a 2 month period after the initial assessment)
Secondary outcome [5] 352279 0
Complications (eg pneumothorax, hemothorax) of diagnostic pleurocentesis by using data-linkage to medical records and chest radiograph performed within 4 hours of the diagnostic pleurocentesis
Timepoint [5] 352279 0
within 4 hours of pleurocentesis

Eligibility
Key inclusion criteria
Stable consecutive patients, both inpatients and outpatients, with pleural effusions requiring diagnostic pleurocentesis alone or followed by therapeutic pleurocentesis, intercostal chest drain or indwelling tunnelled pleural catheter insertion will be prospectively recruited for this study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include those patients on antiplatelet agents within the last seven days, anticoagulants or with an INR >1.5, pregnant patients, respiratory failure, platelet count of <100, patients unable to give informed consent

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)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Results will be presented as mean +/- standard deviation for normally distributed data and median and inter quartile range (IQR) for non-parametric data. Inter-rater agreements of still ultrasound image ratings will be analysed using interclass correlation coefficient (ICC). Differences between collated hand-held and standard image ratings will be assessed using paired t-tests or Mann Whitney U test depending on the data distribution. Live Likert rating scores will be analysed via the Wilcoxon Ranked sum test. Associations between image quality and patient factors will be assessed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/05/2017
Date of last participant enrolment
Anticipated
Actual
6/04/2018
Date of last data collection
Anticipated
Actual
6/04/2018
Sample size
Target
69
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11749 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 23835 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300546 0
Hospital
Name [1] 300546 0
Respiratory and Sleep Services, Flinders Medical Centre
Country [1] 300546 0
Australia
Funding source category [2] 300601 0
Commercial sector/Industry
Name [2] 300601 0
Signostics-provision of 2 handheld ultrasound machines only on loan from the company
Country [2] 300601 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
2 Flinders Drive
Bedford Park, SA
5042
Country
Australia
Secondary sponsor category [1] 300104 0
None
Name [1] 300104 0
Address [1] 300104 0
Country [1] 300104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301342 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301342 0
Office For Research
Ward 6C, Room 6A219
Flinders Medical Centre
2 Flinders Drive
Bedford Park, SA
5042
Ethics committee country [1] 301342 0
Australia
Date submitted for ethics approval [1] 301342 0
08/03/2017
Approval date [1] 301342 0
17/05/2017
Ethics approval number [1] 301342 0
51.17

Summary
Brief summary
Ultrasound assessment has improved the safety and accuracy of pleural procedures. Highly portable handheld ultrasound technology been developed, however has not been validated for this purpose. The aim of this study is to examine the ability of handheld ultrasound to determine a safe site for pleurocentesis. We hypothesize that the handheld ultrasound will be equivalent to the standard ultrasound.
Trial website
Not applicable
Trial related presentations / publications
American Thoracic Society 2018 Conference: Rapid poster presentation
Handheld ultrasound compared with standard ultrasound in the evaluation of pleural effusions
Sarah Newhouse (1), Jason D’Costa (1,2) , Brendan Dougherty (1),Jeff Bowden (1,2) ,Chee Chong (3), Paul Cafarella (1,2) , Anand Rose (1,2)
1. Respiratory and Sleep Services, Flinders Medical Centre, Adelaide, SA, Australia
2. Flinders University School of Medicine, Adelaide, SA, Australia
3. Department of Radiology, Flinders Medical Centre, Adelaide, SA, Australia
Public notes

Contacts
Principal investigator
Name 86678 0
Dr Sarah Newhouse
Address 86678 0
Respiratory and Sleep Services
Flinders Medical Centre
2 Flinders Drive
Bedford Park, SA
5042
Country 86678 0
Australia
Phone 86678 0
+61 08 8204 5511
Fax 86678 0
Email 86678 0
[email protected]
Contact person for public queries
Name 86679 0
Dr Sarah Newhouse
Address 86679 0
Respiratory and Sleep Services
Flinders Medical Centre
2 Flinders Drive
Bedford Park, SA
5042
Country 86679 0
Australia
Phone 86679 0
+61 08 8204 5511
Fax 86679 0
Email 86679 0
[email protected]
Contact person for scientific queries
Name 86680 0
Dr Sarah Newhouse
Address 86680 0
Respiratory and Sleep Services
Flinders Medical Centre
2 Flinders Drive
Bedford Park, SA
5042
Country 86680 0
Australia
Phone 86680 0
+61 08 8204 5511
Fax 86680 0
Email 86680 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
SourceTitleYear of PublicationDOI
EmbaseIs Bigger Really Better? Comparison of Ultraportable Handheld Ultrasound with Standard Point-of-Care Ultrasound for Evaluating Safe Site Identification and Image Quality prior to Pleurocentesis.2020https://dx.doi.org/10.1159/000505698
N.B. These documents automatically identified may not have been verified by the study sponsor.