Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000747224
Ethics application status
Approved
Date submitted
8/02/2018
Date registered
4/05/2018
Date last updated
9/04/2019
Date data sharing statement initially provided
9/04/2019
Date results information initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of different two positions on the right neck vein in healthy volunteers
Scientific title
Comparison Effect of Right Lateral Tilt Position and Trendelenburg Position on Right Internal Jugular Vein in healthy volunteers
Secondary ID [1] 294677 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of Right Lateral Tilt Position and Trendelenburg Position on Right Internal Jugular Vein in healthy volunteers. 306504 0
Condition category
Condition code
Cardiovascular 305616 305616 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The right internal jugulary vein (RIJV) cross-sectional area (CSA) and the anatomical relationship with the carotid artery (CA) will be assessed using a two-dimensional
ultrasound machine by an anaesthetist who is experienced in this matter in outpatient facility.The measurement process is planned to last approximately 20 minutes for each person.Measurements will be performed in the doctor's office. All ultrasonography images will be stored, and measurements will be performed later by different blinded investigator.
Intervention code [1] 300268 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304730 0
The effect of different body positions on the right internal juguler vein (IJV) cross-sectional area (CSA) measured by ultrasound.
This measurement will be repeated for four position (Baseline Position, 10° Right Tilt Position, 10° Trendelenburg Position and 10° Right Tilt + 10°Trendelenburg Position).
Timepoint [1] 304730 0
Every healthy volunteer will be measured only once for every four positions of this volunteer.
Secondary outcome [1] 345219 0
Nil
Timepoint [1] 345219 0
Nil

Eligibility
Key inclusion criteria
Healthy volunteers older than 18 yr, ASA physical status I.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers with previous right IJV catheterization, anatomical malformations of IJV, previous neck surgery, congenital heart disease, concurrent pulmonary disease that might influence the hemodynamics of the right heart, increased intracranial pressure, or hemodynamic instability were excluded from the present study.

Study design
Purpose of the study
Educational / counselling / training
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2018
Actual
6/04/2019
Date of last participant enrolment
Anticipated
Actual
6/04/2019
Date of last data collection
Anticipated
Actual
6/04/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 9568 0
Turkey
State/province [1] 9568 0

Funding & Sponsors
Funding source category [1] 298619 0
Hospital
Name [1] 298619 0
Konya Egitim ve Arastirma Hastanesi
Country [1] 298619 0
Turkey
Primary sponsor type
Individual
Name
Mehmet Selçuk Uluer
Address
Konya Training and Research Hospital, Haci Saban Mah. Yeni Meram Cad. No:97 Posta kodu (Zip Code): 42090 Meram / KONYA
Country
Turkey
Secondary sponsor category [1] 297785 0
None
Name [1] 297785 0
Address [1] 297785 0
Country [1] 297785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300199 0
Necmettin Erbakan Universitesi Meram Tip Fakültesi Etik Kurul
Ethics committee address [1] 300199 0
Necmettin Erbakan Üniversitesi Meram Tip Fakültesi
Akyokus - Meram / KONYA
Posta Kodu: 42080
Ethics committee country [1] 300199 0
Turkey
Date submitted for ethics approval [1] 300199 0
06/11/2017
Approval date [1] 300199 0
09/01/2018
Ethics approval number [1] 300199 0

Summary
Brief summary
To evaluate the effects of right lateral tilt and trendelenburg positions on the area of the internal juguler venous cross section, size, and the relationship with the right internal juguler venous carotid artery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80906 0
Dr Mehmet Selçuk Uluer
Address 80906 0
Konya Training and Research Hospital, Haci Saban Mah. Yeni Meram Cad. No:97 Posta kodu (Zip Code): 42090 Meram / KONYA
Country 80906 0
Turkey
Phone 80906 0
+90 332 221 00 00
Fax 80906 0
Email 80906 0
drmehmetselcuk@gmail.com
Contact person for public queries
Name 80907 0
Dr Mehmet Selçuk Uluer
Address 80907 0
Konya Training and Research Hospital, Haci Saban Mah. Yeni Meram Cad. No:97 Posta kodu (Zip Code): 42090 Meram / KONYA
Country 80907 0
Turkey
Phone 80907 0
+90 332 221 00 00
Fax 80907 0
Email 80907 0
drmehmetselcuk@gmail.com
Contact person for scientific queries
Name 80908 0
Dr Mehmet Selçuk Uluer
Address 80908 0
Konya Training and Research Hospital, Haci Saban Mah. Yeni Meram Cad. No:97 Posta kodu (Zip Code): 42090 Meram / KONYA
Country 80908 0
Turkey
Phone 80908 0
+90 332 221 00 00
Fax 80908 0
Email 80908 0
drmehmetselcuk@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.