Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000200684
Ethics application status
Approved
Date submitted
1/02/2023
Date registered
24/02/2023
Date last updated
28/03/2024
Date data sharing statement initially provided
24/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Inter-rater reliability of critical care transthoracic echocardiography findings amongst cardiac sonographers, junior clinicians and senior clinicians: a prospective study
Scientific title
Inter-rater reliability of critical care transthoracic echocardiography findings amongst cardiac sonographers, junior clinicians and senior clinicians: a prospective study
Secondary ID [1] 308884 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transthoracic echocardiography 328878 0
Condition category
Condition code
Cardiovascular 325871 325871 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The purpose of this trial is to assess the agreement between different groups performing critical care echocardiography. The three participant groups are sonographers, junior clinicians and senior clinicians. From each participant group, 3 will be randomly selected (via a random number generator) to perform a focussed transthoracic echocardiogram on a consented intensive care patient. These studies are expected to take approximately 15 minutes in duration (scanning time). The studies will be performed sequentially, all within a limited time frame of each other (target of 4 hours [half a day]) to have all of the studies performed on any given patient.
The echocardiographic findings will not be used to guide patient care but are instead being used to assess agreement and reliability across the three participant groups.
Intervention code [1] 325331 0
Not applicable
Comparator / control treatment
There is no gold standard for this study however it is likely that the sonographers will have the highest agreement therefore they are the control group and the clinician groups will be the comparator groups.
Control group
Active

Outcomes
Primary outcome [1] 333707 0
Inter-rater reliability across three pre-defined groups (sonographers, junior clinicians and senior clinicians) assessed with Krippendorfs alpha. The primary outcomes are echocardiographic measures as follows:

1. Subjective assessment of left ventricular systolic function (normal, mild impairment, moderate impairment, severe impairment, hyperdynamic)
Timepoint [1] 333707 0
At time of echocardiographic study
Primary outcome [2] 333770 0
2. Mitral annular plane systolic excursion (MAPSE) at the medial and lateral annulus in mm using transthoracic echocardiography
Timepoint [2] 333770 0
At time of echocardiographic study
Primary outcome [3] 333771 0
Left ventricular outflow tract diameter in mm using transthoracic echocardiography
Timepoint [3] 333771 0
At time of echocardiographic study
Secondary outcome [1] 418236 0
(primary outcome) 4: Velocity/Time integral of the left ventricular outflow tract using transthoracic echocardiography
Timepoint [1] 418236 0
At time of echocardiographic study
Secondary outcome [2] 418237 0
(primary outcome) 5: subjective assessment of the systolic function of the right ventricle (normal, mild impairment, moderate impairment, severe impairment, hyperdynamic) using transthoracic echocardiography
Timepoint [2] 418237 0
At time of echocardiographic study
Secondary outcome [3] 418238 0
(primary outcome) 6: tricuspid annular plane systolic excursion (TAPSE) at the lateral annulus (in mm) using transthoracic echocardiography
Timepoint [3] 418238 0
At time of echocardiographic study
Secondary outcome [4] 418239 0
(primary outcome) 7: Systolic velocity using tissue Doppler of the lateral annulus of the right ventricle (S') (cm/s) using transthoracic echocardiography
Timepoint [4] 418239 0
At time of echocardiographic study
Secondary outcome [5] 418240 0
(primary outcome) 8: basal diameter of the right ventricular cavity (in mm) using transthoracic echocardiography
Timepoint [5] 418240 0
at time of echocardiographic study
Secondary outcome [6] 418241 0
(primary outcome) 9: mid cavity diameter of the right ventricle (in mm) using transthoracic echocardiography
Timepoint [6] 418241 0
At time of echocardiographic study
Secondary outcome [7] 418242 0
(primary outcome) 10: length of the right ventricular cavity (mm) using transthoracic echocardiography
Timepoint [7] 418242 0
At time of echocardiographic study
Secondary outcome [8] 418243 0
(primary outcome) 11: Pulmonary artery acceleration time (msec) using transthoracic echocardiography
Timepoint [8] 418243 0
At time of echocardiographic study
Secondary outcome [9] 418244 0
(primary outcome) 12: Maximal velocity of the tricuspid regurgitant velocity (m/sec) using transthoracic echocardiography
Timepoint [9] 418244 0
at time of echocardiographic study
Secondary outcome [10] 418245 0
(primary outcome) 13: Inferior vena cava (IVC) assessment (size and collapsibility) using transthoracic echocardiography
Timepoint [10] 418245 0
At time of echocardiographic assessment

Eligibility
Key inclusion criteria
Sonographers: completed training/fully qualified.
Junior clinicians: intensive care or cardiology trainees that have not completed advanced training in echocardiography.
Senior clinicians: physicians who have completed advanced training in echocardiography and/or are fully qualified cardiologists.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary outcome will be assessed with Krippendorfs alpha.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
1/06/2023
Date of last participant enrolment
Anticipated
29/03/2024
Actual
Date of last data collection
Anticipated
29/03/2024
Actual
Sample size
Target
70
Accrual to date
43
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23899 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 39383 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 313099 0
Hospital
Name [1] 313099 0
Nepean Blue Mountains Local Health District
Country [1] 313099 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Nepean Hospital
Derby St, Kingswood
NSW 2747
Country
Australia
Secondary sponsor category [1] 314792 0
None
Name [1] 314792 0
Address [1] 314792 0
Country [1] 314792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312345 0
Nepean Blue Mountains Local Health District Ethics Committee
Ethics committee address [1] 312345 0
Nepean Hospital
Derby St, Kingswood
NSW 2747
Ethics committee country [1] 312345 0
Australia
Date submitted for ethics approval [1] 312345 0
04/11/2022
Approval date [1] 312345 0
15/11/2022
Ethics approval number [1] 312345 0
2022/ETH/01773

Summary
Brief summary
This study aims to compare the agreement in echocardiographic findings between and within three defined groups: cardiac sonographers, junior clinicians and senior clinicians, when performing transthoracic echocardiography on critically unwell patients. This information is vital when comparing scans performed by different operators and making clinical decisions based on the differences between the two scans.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124330 0
Dr Benjamin Gerhardy
Address 124330 0
Nepean Hospital
Derby Street, Kingswood
NSW 2747
Country 124330 0
Australia
Phone 124330 0
+61 429 202373
Fax 124330 0
Email 124330 0
benjamin.gerhardy@health.nsw.gov.au
Contact person for public queries
Name 124331 0
Dr Benjamin Gerhardy
Address 124331 0
Nepean Hospital
Derby Street, Kingswood
NSW 2747
Country 124331 0
Australia
Phone 124331 0
+61 429 202373
Fax 124331 0
Email 124331 0
benjamin.gerhardy@health.nsw.gov.au
Contact person for scientific queries
Name 124332 0
Dr Benjamin Gerhardy
Address 124332 0
Nepean Hospital
Derby Street, Kingswood
NSW 2747
Country 124332 0
Australia
Phone 124332 0
+61 429 202373
Fax 124332 0
Email 124332 0
benjamin.gerhardy@health.nsw.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
As per ethics application and approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18202Study protocol  benjamin.gerhardy@health.nsw.gov.au By contacting the primary investigator on the foll... [More Details]
18203Ethical approval  benjamin.gerhardy@health.nsw.gov.au By contacting the primary investigator on the foll... [More Details]



Results publications and other study-related documents

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Documents added automatically
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