Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000982011
Ethics application status
Approved
Date submitted
12/11/2010
Date registered
15/11/2010
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using ultrasound to measure the flow of eye blood vessel (Central Retinal Vein) to assess hydration status
Scientific title
In adult pre-operative patients undergoing ocular doppler exam and echocardiography, what is the degree of correlation between Central Retinal Venous flow velocity and Left Ventricular End-Diastolic Area Index?
Secondary ID [1] 252587 0
HREC/10/QPAH/188
Universal Trial Number (UTN)
U1111-1116-7469
Trial acronym
CREVOL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intra-vascular volume status 258083 0
Condition category
Condition code
Cardiovascular 258261 258261 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After obtaining informed consent, the patient's height and weight are recorded. Then the patient is asked to lie supine. ECG dots are placed on the chest to time Echocardiography as per the normal routine. A clear occlusive shield is placed over one eye and an Doppler Ultrasound probe is placed. The Maximum and Minimum flow velocities of the Central Retinal Vein is measured for four cardiac cycles. Then the occlusive shield is removed. This procedure takes approximately 10 minutes.
Intervention code [1] 257113 0
Diagnosis / Prognosis
Comparator / control treatment
A limited trans-thoracic Echocardiogram is performed - An Echocardiography probe is placed over the left side of the sternum after applying conductive gel. A parasternal short axis view of the Left Ventricle is obtained. The left ventricular end diastolic area is recorded for four cardiac cycles. The whole exam takes approximately 10 minutes.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259102 0
Degree of correlation between the Central retinal venous flow velocity and the Left ventricular end-diastolic area index
Timepoint [1] 259102 0
Nil
Secondary outcome [1] 265404 0
Nil
Timepoint [1] 265404 0
Nil

Eligibility
Key inclusion criteria
Adult patients (18 years of age and above), who present for undergoing elective surgery at the QE II Jubilee hospital, Coopers plains, QLD 4108, Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre existing eye diseases like documented Diabetic and hypertensive complications in the eye (Diabetes Mellitus and Hypertension per se do not exclude the patient). 2. Glaucoma 3. Patients who have sustained Eye injuries 4. Patients presenting for Eye surgery 5. Patients who had previous eye surgeries other than uncomplicated cataract removal and minor eye procedures 6. Any other contra-indication to performing a routine ocular Doppler examination 7. Patients presenting for Emergency surgeries 8. Evidence of Increased Intra-cranial pressure 9. History of Epilepsy 10. Patients with evidence of heart failure 11. Pregnant women 12. Children 13. Patients who refuse 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)
All patients belong to only one group. There is no outcome comparison involved.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomization
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
47
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257558 0
Self funded/Unfunded
Name [1] 257558 0
Country [1] 257558 0
Australia
Primary sponsor type
Hospital
Name
QE II JUBILEE HOSPITAL - DEPT. OF ANAESTHESIA
Address
CNR KESSELS RD AND TROUGHTON ST
COOPERS PLAINS
QLD 4108
Country
Australia
Secondary sponsor category [1] 256780 0
None
Name [1] 256780 0
Address [1] 256780 0
Country [1] 256780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259579 0
METRO SOUTH HEALTH SERVICE DISTRICT (EC00167)
Ethics committee address [1] 259579 0
Centres for Health Research (Contracts)
Level 2, Building 35
Princess Alexandra Hospital
199 Ipswich Road Woolloongabba, Brisbane, Queensland, 4102, AUSTRALIA
Tel: 07 3176 2115
Tel: 07 3176 7672
FAX: 07 3176 7667
Ethics committee country [1] 259579 0
Australia
Date submitted for ethics approval [1] 259579 0
20/08/2010
Approval date [1] 259579 0
10/11/2010
Ethics approval number [1] 259579 0
HREC/10/QPAH/188

Summary
Brief summary
The primary purpose of this study is to test a simple and non-invasive method for estimating intravascular volume status. Estimation of intravascular volume status (hydration status) is of crucial importance in treating patients in various specialties including intensive care. The current methods available are mostly invasive. The non-invasive methods currently in vogue are resource intensive. Hence, there is a need for a simple, consistent and reliable measure for assessment of intravascular volume status. With this view, this study proposes the use of Central Retinal Venous blood flow velocity as an index of intravascular volume status.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31583 0
Address 31583 0
Country 31583 0
Phone 31583 0
Fax 31583 0
Email 31583 0
Contact person for public queries
Name 14830 0
DR. BALAJI BIKSHANDI
Address 14830 0
DEPT. OF ANAESTHESIA
QE II JUBILEE HOSPITAL
COOPERS PLAINS
QLD 4108
Country 14830 0
Australia
Phone 14830 0
+61 7 3275 6111
Fax 14830 0
Email 14830 0
balaji.md@gmail.com
Contact person for scientific queries
Name 5758 0
DR. BALAJI BIKSHANDI
Address 5758 0
9/200 Jackson Road
Sunnybank Hills
QLD 4109
Country 5758 0
Australia
Phone 5758 0
+61 7 3344 1971
Fax 5758 0
Email 5758 0
balaji.md@gmail.com

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
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Documents added automatically
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