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Comparison of In-plane with Out-plane Methods of Sonography for Internal Jugular Vein Catheterization in End Stage Liver Disease Patients

Protocol summary

Summary
Objectives: The aim of this study was to compare two methods of out plane method (short axis) internal jugular vein catheterization with ultrasound –guided and internal jugular vein catheterization by using ultrasound- guided by in plane method (long-axis) in terms of success rate and the percentage of short-term and long-term complications, especially in patients with coagulopathy, possibility of trauma, hematoma and venous thrombosis. Although, this procedure has significant complications as well as benefits, including failure at catheter placement, arterial injury, hematoma, pneumothorax, hemothorax, arrhythmias and brachial plexus injury. Ultrasound is used to improve the catheterization process, increasing the success rate and reduce complications Inclusion criteria are 14 years of age and over, end stage liver disease, coagulopathy, indication for internal jugular vein catheterization. Exclusion criteria: refusal for consent, contraindication for internal jugular vein catheterization (e.g., infection of the site, thyroid enlargement, neck movement limitation.) All patients over 14 years who were undergoing liver transplantation with coagulopathy were enrolled to the study. In this clinical trial, 80 patients were divided into two groups. Intravenous catheterization was done by an Anesthesiologist by using one of the two methods of out plane or in plane catheterization. And all the information contained in the form accurately recorded. While, delayed complications were recorded in ICU, and data was checked and success rates of internal jugular vein catheterization with in-plane and out plane techniques were determined, at the time of catheter insertion, in the operating room, 24 hours after catheter insertion, one week after catheter insertion.

General information

Acronym
ICU(Intensive Care Unit)
IRCT registration information
IRCT registration number: IRCT2014112619470N3
Registration date: 2015-01-09, 1393/10/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-09, 1393/10/19
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of In-plane with Out-plane Methods of Sonography for Internal Jugular Vein Catheterization in End Stage Liver Disease Patients
Public title
Comparison of Different Techniques of Internal Jugular Vain Cathetrization in Liver Disease Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 14 years of age and over, End stage liver disease, Coagulopathy, Indication for Internal Jugular Vein Catheterization. Exclusion Criteria: Refusal for consent, Contraindication for Internal Jugular Vein Catheterization (e.g., Infection of the Site, Thyroid Enlargement, Neck Movement Limitation )
Age
From 14 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CP-P-9366-6056

Health conditions studied

1

Description of health condition studied
Disease of Liver
ICD-10 code
K71.6
ICD-10 code description
Toxic Liver Disease with Hepatitis, not Elsewhere Classified

Primary outcomes

1

Description
To Determine the success rate of internal jugular vain catheterization with in-plane technique
Timepoint
at the time of catheter insertion, in the operating room, 24 hours after catheter insertion, one week after catheter insertion
Method of measurement
Observasion

Secondary outcomes

1

Description
To Determine the success rate of internal jugular vain cathettion with out-plane techniqueeriza
Timepoint
at the time of catheter insertion, in the operating room, 24 hours after catheter insertion, one week after catheter insertion
Method of measurement
Observasion

Intervention groups

1

Description
In the intervention group (1):The end stage liver disease patients will be undertaken of ultrasound -guided in-plane internal jugular vein catheterization.
Category
Prevention

2

Description
In the intervention group (2):The end stage liver disease patients will be undertaken of ultrasound -guided out- plane internal jugular vein catheterization.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazee Hospital
Full name of responsible person
Dr Zahra Nikeghbalian
Street address
Zand Street, Namazee Hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Nikeghbalian
Position
Physician, Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3235 7282
Fax
Email
nikeghbal_z@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Mohammad Bagher Khosravi
Position
Anesthesiologist, Transplant Fellowship
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
khosravimb@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
English Consultant,Anesthesiology Research Center Staff
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 36474270
Fax
Email
masihif@sums.ac.com; masihifarzaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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