Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000392460
Ethics application status
Approved
Date submitted
14/10/2015
Date registered
24/03/2016
Date last updated
24/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of varying entry points and Trendelenburg positioning degrees in internal jugular vein area measurements of newborns weighing between 3000-3500 grams
Scientific title
Effects of varying entry points and Trendelenburg positioning degrees in internal jugular vein area measurements of newborns weighing between 3000-3500 grams
Secondary ID [1] 287622 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Internal jugular vein cannulation in neonates 296435 0
Condition category
Condition code
Cardiovascular 296695 296695 0 0
Normal development and function of the cardiovascular system
Anaesthesiology 296988 296988 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are planning to compare two cannulation sides for internal jugular vein in terms of antero-posterior and lateral diameters and area in 100 healthy neonates weighed between 3000-3500 grams. The first (superior) measurement point will be the apex of Sedillot's Triangle (Clavicula-Sternal and clavicular heads of the sternocloidomastoid muscle). The second (inferior) measurement point will be midpoint of supraclavicular notch. For each trendelenburg degree, six measurements (including the first and second measurement points) will be made in different head rotation degrees of zero (neutral position), 15 degrees and 30 degrees to the left side.
The measurements will be performed primarily in horizontal position and then in 15 degrees and 30 degrees Trendelenburg position with ultrasound by the same anesthesiologist. The data will be recorded as follows:
IJV area (N): Superior/ Inferior
IJV AP(antero-posterior) diameter (N): Superior/ Inferior
IJV laterar diameter (N): Superior/ Inferior
Carotis-IJV distance (N): Superior/ Inferior
N reffers to as head in neutral position
IJV area (15): Superior/ Inferior
IJV AP(antero-posterior) diameter (15): Superior/ Inferior
IJV laterar diameter (15): Superior/ Inferior
Carotis-IJV distance (15): Superior/ Inferior
15 reffers to as head in rotation 15 degrees to the left-side
IJV area (30): Superior/ Inferior
IJV AP(antero-posterior) diameter (30): Superior/ Inferior
IJV laterar diameter (30): Superior/ Inferior
Carotis-IJV distance (30): Superior/ Inferior
30 reffers to as head in rotation 30 degrees to the left-side
It will take 1 minute (max.) to get data from each point and 1 minute (max.) to give the appropriate planned position. At the end of one neonates observation, eighteen data will be collected. It will last about 20 minutes to get the results from each patient.The interventional study will last approximately 1 week.
Intervention code [1] 293019 0
Treatment: Other
Comparator / control treatment
As standart care for internal jugular vein cannulation; we use ulrasound guided technique for each neonate, by inferior approach in 30 degrees Trendelenburg position and 30 degrees head rotation to the left.
Control group
Active

Outcomes
Primary outcome [1] 296336 0
By using ultrasound guided technique, we will determine which cannulation point, Trendelenburg degree and head rotation degree combination is optimum for widest vessel diameter localization in neonates.
Timepoint [1] 296336 0
After completion of all eighteen measurements in all neonates and the statistical analysis of the data.
Secondary outcome [1] 318200 0
None
Timepoint [1] 318200 0
N/A

Eligibility
Key inclusion criteria
Newborn infants between 3000-3500 grams of weight
Minimum age
1 Days
Maximum age
30 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Weighed less than 3000 grams
Weighed more than 3500 grams
Mass or puffiness in the neck area
Need for mechanical ventlation

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/11/2015
Date of last participant enrolment
Anticipated
Actual
1/12/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
58
Recruitment outside Australia
Country [1] 7217 0
Turkey
State/province [1] 7217 0
Istanbul

Funding & Sponsors
Funding source category [1] 292203 0
Self funded/Unfunded
Name [1] 292203 0
Pelin Karaaslan
Country [1] 292203 0
Turkey
Primary sponsor type
Individual
Name
Pelin Karaaslan
Address
Medipol Mega Hastaneler Kompleksi
Metin Sokak No:4
34214
Bagcilar/Istanbul
TURKEY
Country
Turkey
Secondary sponsor category [1] 290879 0
Individual
Name [1] 290879 0
Kamil Darcin
Address [1] 290879 0
Medipol Mega Hastaneler Kompleksi
Metin Sokak No:4
34214
Bagcilar/Istanbul
TURKEY
Country [1] 290879 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293686 0
Istanbul Medipol University Ethics Committee of Clinical Trials
Ethics committee address [1] 293686 0
Ataturk Bulvari, No:27
34083
Unkapani/Istanbul
Ethics committee country [1] 293686 0
Turkey
Date submitted for ethics approval [1] 293686 0
08/05/2015
Approval date [1] 293686 0
16/05/2015
Ethics approval number [1] 293686 0
10840098-14

Summary
Brief summary
We are planning to compare two cannulation sides for internal jugular vein in terms of antero-posterior and lateral diameters and area in 58 healthy neonates weighed between 3000-3500 grams. The measurements will be made from two access points for internal jugular vein catheterization (superior and inferior) in 3 different Trendelenburg positions (horizontal, 15 and 30 degrees) and in different degrees of head rotation (zero, 15 and 30 degrees to the left) for each Trendelenburg positioning. The measurements will be performed by using ultrasound by the same anesthesiologist.
Trial website
Trial related presentations / publications
Public notes
The sample size was slightly increased in order to reach the target sample size just in case of a need for exclusion.

Contacts
Principal investigator
Name 60854 0
Dr Pelin Karaaslan
Address 60854 0
Medipol Mega Hastaneler Kompleksi
Metin Sokak No:4
34214
Bagcilar/Istanbul
Country 60854 0
Turkey
Phone 60854 0
+905057657550
Fax 60854 0
Email 60854 0
[email protected]
Contact person for public queries
Name 60855 0
Dr Pelin Karaaslan
Address 60855 0
Medipol Mega Hastaneler Kompleksi
Metin Sokak No:4
34214
Bagcilar/Istanbul
Country 60855 0
Turkey
Phone 60855 0
+905057657550
Fax 60855 0
Email 60855 0
[email protected]
Contact person for scientific queries
Name 60856 0
Dr Pelin Karaaslan
Address 60856 0
Medipol Mega Hastaneler Kompleksi
Metin Sokak No:4
34214
Bagcilar/Istanbul
Country 60856 0
Turkey
Phone 60856 0
+905057657550
Fax 60856 0
Email 60856 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
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