Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000237684
Ethics application status
Approved
Date submitted
14/02/2014
Date registered
5/03/2014
Date last updated
5/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of the Trendelenburg Position and Passive Leg Elevation on Internal Jugular Vein Catheterization in the Intensive Care Unit
Scientific title
The effect of the Trendelenburg position and passive leg elevation on the change in size of the right internal jugular vein to exhibit optimal position for internal jugular vein catheterization in intensive care unit patients.
Secondary ID [1] 284100 0
nil
Universal Trial Number (UTN)
U1111-1152-7580
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill patients in intensive care requiring catheterization. 291173 0
Condition category
Condition code
Anaesthesiology 291511 291511 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred twenty intensive care patients who were intubated and mechanically ventilated were enrolled in the study. Patients were randomly divided into four groups, each consisting of 30 patients.Group I: Control group: Supine position,Group II: 10 degree Trendelenburg position,
Group III: 50 degree passive leg elevation position,
Group IV: 10 degree Trendelenburg position plus 50 degree passive leg elevation position. For all patients, transverse and vertical length, depth, and surface of the internal jugular vein were measured first in the supine and then in the intervention position.Anterior-posterior and transfer diameter, cross sectional area (CSA) and depth were calculated by the same anesthesiologist from the recorded internal jugular vein images. CSA was calculated by the planimeter method.
For depth measurement, the distance from the skin surface to the anterior wall of IJV was measured.After giving the position for the intervention (internal juguler vein catheterization) the chronometer was started. If the time to the vein puncture was more than 20 minutes or any complications occurred during the procedure, that patient was not included in the study.
Intervention code [1] 288793 0
Treatment: Other
Comparator / control treatment
Supine position.
Control group
Active

Outcomes
Primary outcome [1] 291482 0
After giving the position for the intervention, the chronometer was started. To determine the extent of the increase in internal jugular vein (IJV) size(Anterior-posterior and transfer diameter, cross sectional area (CSA) and depth ) in the patients who received the Trendelenburg position, passive leg elevation, or both for is assessed via USG. IJV size were calculated by the same anesthesiologist from the recorded internal jugular vein images. CSA was calculated by the planimeter method.
For depth measurement, the distance from the skin surface to the anterior wall of IJV was measured.
Timepoint [1] 291482 0
Primary timepoint was assessed immediately after internal jugular vein catheterization.
Secondary outcome [1] 306878 0
To investigate the effect of this increase in IJV size on the success of the first attempt at catheterization.The success of the first attempt at was assessed as observation by the the medical team performing the internal jugular vein catheterization..
Timepoint [1] 306878 0
Secondary timepoint was assessed immediately after internal jugular vein catheterization
Secondary outcome [2] 307070 0
To investigate the effect of this increase in IJV size on mechanical complications such as arterial puncture, hematoma, pneumothorax...etc. Mechanical complications ( arterial puncture, hematoma.) was assessed by observation by the the medical team performing the internal jugular vein catheterization. Pneumothorax was assessed by chest X-ray in suspicious patients after internal jugular vein catheterization.
Timepoint [2] 307070 0
Mechanical complications (arterial puncture, hematoma.) was assessed immediately after internal jugular vein catheterization.Pneumothorax was assessed by chest X-ray in suspicious patients within 1 hours after internal jugular vein catheterization

Eligibility
Key inclusion criteria
Intensive care patients who were intubated and mechanically ventilated were enrolled in the study. Patients requiring catheterization, with BMI <30 kg/m2 and blood pressure >90/60 mmHg, who were hemodynamically stable.We enrolled patients, ARDS, postoperative
respiratory failure, neuromuscular disease, pneumonia,
cerebrovascular accident, metabolic disease,
organophosphorus poisoning and catheterization
was performed for the purpose of intravenous fluids,
total parenteral nutrition
and hemodynamic monitoring.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring immediate catheterization, with BMI >30 kg/m2 and blood pressure <90/60 mmHg, who were hemodynamically instable, receiving vasoactive medications, who had coronary artery disease, gastric reflux, elevated intracranial pressure, previous catheterization at the same site that would make the intervention difficult for venous cannulation, pacemaker, skeletal deformity, and untreated coagulopathy (INR >2, APTT >1.5x higher, platelet count <50,000/mm3).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/07/2013
Date of last participant enrolment
Anticipated
28/02/2014
Actual
10/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 5826 0
Turkey
State/province [1] 5826 0

Funding & Sponsors
Funding source category [1] 288730 0
University
Name [1] 288730 0
Necmettin Erbakan University Department of Intensive Care Unit
Country [1] 288730 0
Turkey
Primary sponsor type
University
Name
Necmettin Erbakan University
Address
Necmettin Erbakan University Department of Intensive Care Unit
Meram School of Medicine 42080
Meram, Konya, Turkey
Country
Turkey
Secondary sponsor category [1] 287429 0
None
Name [1] 287429 0
Address [1] 287429 0
Country [1] 287429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290566 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 290566 0
Necmettin Erbakan University
Meram School of Medicine
Akyokus, Meram,Konya
42080
Ethics committee country [1] 290566 0
Turkey
Date submitted for ethics approval [1] 290566 0
29/03/2013
Approval date [1] 290566 0
05/04/2013
Ethics approval number [1] 290566 0
2013.21

Summary
Brief summary
This study aims to establish the change in the size of the right internal jugular vein by placing the patient in the Trendelenburg position, assuming a passive leg elevation, or both, as well as the success of this change and its effect on mechanical complications.One hundred twenty intensive care patients who were intubated and mechanically ventilated were enrolled in the study. Patients were randomly divided into four groups, each consisting of 30 patients. For all patients, transverse and vertical length, depth, and surface of the internal jugular vein were measured first in the supine and then in the intervention position.Group I: Control group: Supine position
Group II: 10 degrees Trendelenburg position,
Group III: 50 degrees passive leg elevation position,
Group IV: 10 degrees Trendelenburg position plus 50 degrees passive leg elevation position. Intervention was performed in the supine position in the control group and in the latter in other groups. The change observed in the vein size, along with the positional change and the success of this intervention and its effect on mechanical complications were determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45906 0
A/Prof Funda Gok
Address 45906 0
Necmettin Erbakan University Department of Anesthesiology and Reanimation Meram School of Medicine, 42080 Meram Konya
Country 45906 0
Turkey
Phone 45906 0
+903322237030
Fax 45906 0
Email 45906 0
[email protected]
Contact person for public queries
Name 45907 0
Prof Alper Yosunkaya
Address 45907 0
Necmettin Erbakan University Department of Anesthesiology and Reanimation Meram School of Medicine, 42080 Meram Konya
Country 45907 0
Turkey
Phone 45907 0
+903322237161
Fax 45907 0
Email 45907 0
[email protected]
Contact person for scientific queries
Name 45908 0
Prof Alper Yosunkaya
Address 45908 0
Necmettin Erbakan University Department of Anesthesiology and Reanimation Meram School of Medicine, 42080 Meram Konya
Country 45908 0
Turkey
Phone 45908 0
+903322237161
Fax 45908 0
Email 45908 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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