Protocol summary

Summary
Objectives: The aim of this study is to compare sonographic right internal jugular vein catheterization with short axis method in nautra Ihead position via medial-oblique technique in 45 degree head position in open heart surgery. Research Design: Conduction of a randomized, double-blind, clinical trial. Inclusion criteria of the study were as follows: Open-heart surgery patients, age above 18 years, Patients’ consent to participate. Exclusion criteria of the study were: cannulation site infection/wound/hematoma/emphysema and surgery, intensive coagulopathy, IJV cannulation during the past 72 hours, recent cervical trauma with movement limitations, anatomical changes in the cervical vessels, IJV thrombosis with the short axis technique in open-heart surgery patients. Intervention: After induction of anesthesia 80 patients were divided into two groups of 40, Short Axis Group and Medial-Oblique Group. For short-axis technique, the patient’s head was positioned at 0-degree angulation with his trunk. For medial-oblique technique, the patient’s head was tilted to left to 45 degrees between the head and trunk. Venous access time, guide wire time, cannulation time, total attempts for catheterization, total successful first attempts, number of arterial puncture, bleeding and hematoma at the puncture site and proper catheter placement were recorded and success rate of each technique, duration of different catheterization steps, primary mechanical complications for comparison of these techniques were determined in the operating room and also 7 hours after CABG in the ICU by chest X-ray .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015020819470N15
Registration date: 2015-03-14, 1393/12/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-14, 1393/12/23
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
2014-03-21, 1393/01/01
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 sonographic right internal jugular vein catheterization with short axis method in natural head position and medial- oblique method in 45 degree head position in open heart surgery
Public title
Comparison of sonographic right internal jugular vein catheterization with short axis method in natural head position and medial- oblique method in 45 degree head position in open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria :age above 18 years, Open-heart surgery patients. Exclusion criteria : cannulation site infection/wound/hematoma/emphysema and surgery, intensive coagulopathy, IJV cannulation during the past 72 hours, recent cervical trauma with movement limitations, anatomical changes in the cervical vessels, IJV thrombosis with the short axis technique.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
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
2014-05-30, 1393/03/09
Ethics committee reference number
cp-p-9371-7071

Health conditions studied

1

Description of health condition studied
Open Heart Surgery
ICD-10 code
197.1
ICD-10 code description
Other functional disturbances following cardiac surgery

Primary outcomes

1

Description
To Determine the success rate of sonographic right internal jugular vein catheterization with short axis method with 0-degree angulation with his trunk
Timepoint
at the time of catheter insertion, in the operating room, 7 hours after catheter insertion in the ICU
Method of measurement
Observation

Secondary outcomes

1

Description
To Determine the success rate of sonographic right internal jugular vein catheterization with medial-oblique method with45-degree angulation with his trunk
Timepoint
at the time of catheter insertion, in the operating room, 7 hours after catheter insertion in the ICU
Method of measurement
Observation

Intervention groups

1

Description
Intervention group 1: for internal jugular vein catheterization with short-axis technique, the patient’s head was positioned at 0-degree angulation with his trunk
Category
Treatment - Surgery

2

Description
Intervention group 2:for internal jugular vein catheterization with medial-oblique technique, the patient’s head was tilted to left to 45 degrees between the head and trunk.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Mohammad Mehdi Derakhshan
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
Mohammad Mehdi Derakhshan
Position
Anesthesiologist,Cardioanesthetic fellowship
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
mmderakh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Kamalipour
Position
Cardioanesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 917 701 2654
Fax
Email
kamalipour <kamalih@yahoo.com
Web page address

Person responsible for updating data

Contact

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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