ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Transthoracic echocardiography

Condition category

Condition code

Cardiovascular

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]

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]

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]

At time of echocardiographic study

Primary outcome [2]

2. Mitral annular plane systolic excursion (MAPSE) at the medial and lateral annulus in mm using transthoracic echocardiography

Timepoint [2]

At time of echocardiographic study

Primary outcome [3]

Left ventricular outflow tract diameter in mm using transthoracic echocardiography

Timepoint [3]

At time of echocardiographic study

Secondary outcome [1]

(primary outcome) 4: Velocity/Time integral of the left ventricular outflow tract using transthoracic echocardiography

Timepoint [1]

At time of echocardiographic study

Secondary outcome [2]

(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]

At time of echocardiographic study

Secondary outcome [3]

(primary outcome) 6: tricuspid annular plane systolic excursion (TAPSE) at the lateral annulus (in mm) using transthoracic echocardiography

Timepoint [3]

At time of echocardiographic study

Secondary outcome [4]

(primary outcome) 7: Systolic velocity using tissue Doppler of the lateral annulus of the right ventricle (S') (cm/s) using transthoracic echocardiography

Timepoint [4]

At time of echocardiographic study

Secondary outcome [5]

(primary outcome) 8: basal diameter of the right ventricular cavity (in mm) using transthoracic echocardiography

Timepoint [5]

at time of echocardiographic study

Secondary outcome [6]

(primary outcome) 9: mid cavity diameter of the right ventricle (in mm) using transthoracic echocardiography

Timepoint [6]

At time of echocardiographic study

Secondary outcome [7]

(primary outcome) 10: length of the right ventricular cavity (mm) using transthoracic echocardiography

Timepoint [7]

At time of echocardiographic study

Secondary outcome [8]

(primary outcome) 11: Pulmonary artery acceleration time (msec) using transthoracic echocardiography

Timepoint [8]

At time of echocardiographic study

Secondary outcome [9]

(primary outcome) 12: Maximal velocity of the tricuspid regurgitant velocity (m/sec) using transthoracic echocardiography

Timepoint [9]

at time of echocardiographic study

Secondary outcome [10]

(primary outcome) 13: Inferior vena cava (IVC) assessment (size and collapsibility) using transthoracic echocardiography

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Nepean Hospital - Kingswood

Recruitment postcode(s) [1]

2747 - Kingswood

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Nepean Blue Mountains Local Health District

Address [1]

Nepean Hospital
Derby St, Kingswood
NSW 2747

Country [1]

Australia

Primary sponsor type

Hospital

Name

Nepean Hospital

Address

Nepean Hospital
Derby St, Kingswood
NSW 2747

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Nepean Blue Mountains Local Health District Ethics Committee

Ethics committee address [1]

Nepean Hospital
Derby St, Kingswood
NSW 2747

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/11/2022

Approval date [1]

15/11/2022

Ethics approval number [1]

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

Dr Benjamin Gerhardy

Address

Nepean Hospital
Derby Street, Kingswood
NSW 2747

Country

Australia

Phone

+61 429 202373

Fax

[email protected]

Contact person for public queries

Name

Benjamin Gerhardy

Address

Nepean Hospital
Derby Street, Kingswood
NSW 2747

Country

Australia

Phone

+61 429 202373

Fax

[email protected]

Contact person for scientific queries

Name

Benjamin Gerhardy

Address

Nepean Hospital
Derby Street, Kingswood
NSW 2747

Country

Australia

Phone

+61 429 202373

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

As per ethics application and approval

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18202	Study protocol			[email protected]	By contacting the primary investigator on the foll... [More Details]
18203	Ethical approval			[email protected]	By contacting the primary investigator on the foll... [More Details]

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.

Trial Review

Documents added manually

Documents added automatically