Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001339741
Ethics application status
Approved
Date submitted
4/12/2013
Date registered
9/12/2013
Date last updated
9/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Right Ventricular Clearance Index (RVCI): A Simple New Parameter To Assess The Right Ventricular Systolic Function Using Contrast Echocardiography In Critically Ill Patients
Scientific title
Right Ventricular Clearance Index (RVCI): A Simple New Parameter To Assess The Right Ventricular Systolic Function Using Contrast Echocardiography In Critically Ill Patients
Secondary ID [1] 283647 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Right Ventricular Dysfunction Assessment In Critically Ill Patients 290594 0
Condition category
Condition code
Cardiovascular 290981 290981 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergo both transthoracic and transesophageal echocardiography performed by an experienced operator. The approximate duration of examination is 30 minutes. Both the transthoracic and transesophageal echocardiography are undertaken only one occasion.

During transthoracic echocardiography, we measure TAPSE (tricuspid annular plane systolic excurtion), S' (tricuspid annular plane systolic peak velocity), and PASP (pulmonary artery systolic pressure).

During the transesophageal echocardiography, we perform a contrast test by injecting 5 ml of ultrasound contrast agent as a bolus through the central venous catheter. The time taken by the contrast agent to totally disappear from the right ventricular is called T and is noted in seconds. The right ventricular clearance index (RVCI) is defined as follows: RVCI= (T/HR)*100 (HR = heart rate).

The right atrial pressure (RAP) is measured using the central venous catheter.

We will test correlations between RVCI, TAPSE and S'.

We will also test correlations between RVCI, PASP and RAP

We will study the ability of RVCI to detect right ventricular systolic dysfunction defined with TAPSE<16mm or S'<10cm/s
Intervention code [1] 288346 0
Diagnosis / Prognosis
Intervention code [2] 288347 0
Early detection / Screening
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290964 0
Correlation between RVCI, TAPSE and S'
Timepoint [1] 290964 0
cross-sectionnally
Primary outcome [2] 290965 0
Ability of RVCI to detect right ventricular systolic dysfunction defined by TAPSE<16mm or S'<10cm/s
Timepoint [2] 290965 0
cross-sectionnally
Secondary outcome [1] 305683 0
Correlations between RVCI, PASP and RAP
Timepoint [1] 305683 0
cross-sectionnally

Eligibility
Key inclusion criteria
1 Critically ill patients
2 Sedated
3 Invasively ventilated
4 With preexisting internal jugular or subclavian central venous catheter
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Transthoracic echocardiography images with poor quality
2 Contraindication to transesophageal echocardiography
3 Impossibility to introduce the transesophageal echocardiography probe
4 If the central venous catheter tip was not in the right atrium
5 Evidence of intracardiac shunt
6 Organic tricuspid regurgitation
7 Surgical procedure on the tricuspid valve

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2013
Actual
2/12/2013
Date of last participant enrolment
Anticipated
15/01/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment outside Australia
Country [1] 5652 0
Tunisia
State/province [1] 5652 0
Tunis

Funding & Sponsors
Funding source category [1] 288324 0
Hospital
Name [1] 288324 0
Military Hospital Of Tunis
Country [1] 288324 0
Tunisia
Primary sponsor type
Hospital
Name
Military Hospital Of Tunis
Address
Montfleury, 1089, Tunis
Country
Tunisia
Secondary sponsor category [1] 287041 0
None
Name [1] 287041 0
Address [1] 287041 0
Country [1] 287041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290218 0
Military Hospital of Tunis Local Ethics Committee
Ethics committee address [1] 290218 0
Military Hospital of Tunis
Montfleury, 1089, Tunis
Ethics committee country [1] 290218 0
Tunisia
Date submitted for ethics approval [1] 290218 0
Approval date [1] 290218 0
25/11/2013
Ethics approval number [1] 290218 0

Summary
Brief summary
The aims of this trial are to study the correlation between right ventricular clearance index(RVCI) and two classical echocardiographic parameters of the right ventricular systolic function: TAPSE and S’ and to test the ability of RVCI to predict right ventricular systolic dysfunction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44518 0
Dr Radhouane BOUSSELMI
Address 44518 0
Radhouane BOUSSELMI
Military Hospital of Tunis
15 Avenue de la Republique
2000 Bardo
Tunis
Country 44518 0
Tunisia
Phone 44518 0
+ 216 22 622 495
Fax 44518 0
Email 44518 0
[email protected]
Contact person for public queries
Name 44519 0
Radhouane BOUSSELMI
Address 44519 0
Radhouane BOUSSELMI
15 Military Hospital of Tunis
Avenue de la Republique
2000 Bardo
Tunis
Country 44519 0
Tunisia
Phone 44519 0
+ 216 22 622 495
Fax 44519 0
Email 44519 0
[email protected]
Contact person for scientific queries
Name 44520 0
Radhouane BOUSSELMI
Address 44520 0
Radhouane BOUSSELMI
Military Hospital of Tunis
15 Avenue de la Republique
2000 Bardo
Tunis
Country 44520 0
Tunisia
Phone 44520 0
+ 216 22 622 495
Fax 44520 0
Email 44520 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.