Protocol summary

Summary
This study is designed to evaluate results of ultrasound guided internal jugular vein catheterization in emergency ward and promotion of its using in Iran. One hundred patients referred to emergency ward of Baqiyatallah Hospital needing internal jugular vein catheterization will randomly assigned to two groups. Catheterization will be accomplished using ultrasound guidance after viewing internal jugular vein in the first group, and using anatomical landmarks in the second group. Patients younger than 14 years old and pregnant women will be exclude from study. Side of catheterization (left or right), risk factors such as hypertension, diabetes mellitus, coagulopathies, ischemic heart disease, cigarette smoking, edema, local masses, shock, cardiac arrest, chronic lung diseases, loss of consciousness, sepsis, malignancy, renal disease, trauma, hepatic failure, hematologic disorders, electrolyte imbalance, respiratory distress, patients under mechanical ventilator and vasodilator drugs infusion will be evaluated. Venous access time, numbers of tries, success rate, and catheter related complications will be compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014081117413N6
Registration date: 2014-08-21, 1393/05/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-21, 1393/05/30
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences, Deputy of Research
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Success Rate and Complications of Internal Jugular Vein Catheterization with and without Ultrasonography Guide in Emergency Ward: a Randomized Clinical Trial
Public title
Internal Jugular Vein Catheterization with and without Ultrasonography Guide
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients referred to emergency ward of Baqiyatallah Hospital needing internal jugular vein catheterization Exclusion criteria: Patients younger than 14 years old; pregnant women; uncontrolled coagulopathies; anticoagulant drugs consumption within the last day
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Baqiyatallah University of Medical Sciences Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Approval date
2013-06-14, 1392/03/24
Ethics committee reference number
28-2

Health conditions studied

1

Description of health condition studied
Internal jugular vein puncture
ICD-10 code
Y62.6
ICD-10 code description
During aspiration, puncture and other catheterization

2

Description of health condition studied
Venous catheter complications
ICD-10 code
T82.4
ICD-10 code description
Mechanical complication of vascular dialysis catheter

Primary outcomes

1

Description
Internal jugular access time
Timepoint
From needle contacts skin to an established venous flow
Method of measurement
Seconds

2

Description
Number of attempts
Timepoint
at catheterization time
Method of measurement
Numbers

3

Description
Catheter related complications
Timepoint
after catheterization
Method of measurement
yes/ no

Secondary outcomes

empty

Intervention groups

1

Description
Ultrasound guided jugular vein catheterization
Category
Treatment - Devices

2

Description
Jugular vein catheterization using anatomical landmarks
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency ward of Baqiyatallah Hospital
Full name of responsible person
Hamidreza Karimi Sari
Street address
Baqiyatallah Hospital, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences, Deputy of Research
Full name of responsible person
Mehrdad Faraji
Street address
Baqiyatallah Hospital, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Sciences, Deputy of Research
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
Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
Full name of responsible person
Hamidreza Karimi Sari
Position
General Practitioner
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
dr.karimih@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Emergency, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran, I
Full name of responsible person
Mehrdad Faraji
Position
Assistant Professor
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
Email
m.faraji@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences (BMSU), Tehran, Iran
Full name of responsible person
Hamidreza Karimi Sari
Position
General Practitioner
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
dr.karimih@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
Loading...