The purpose of this investigation is to improve ultrasound-guided central intravenous access versus traditional approaches. Inclusion criteria: Age>18 years; emergency admission; necessity for Central Intravenous access according to present attending;
Exclusion criteria: Coagulation disorders; any contraindication for Central Access catheterization. Target sample size is 100 of patients admitting in the emergency department, asking them to participate in the research project voluntarily. After determining candidacy, patients will randomly be divided into two groups. In the first group traditional or classic central access catheterization with anatomic landmarks will be done and in the second group ultrasound-guided central intravenous access will be accomplished. Complications of two methods will be compared during presence at emergency room.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504297751N6
Registration date:2015-05-10, 1394/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Davood Farsi
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
dfarsi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of successful rate of Ultrasound-guided Central Intravenous Access versus traditional approaches
Public title
Ultrasonography-Guided Central Intravenous Access
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Age>18 years; emergency admission; necessity for Central Intravenous access according to present attending;
Exclusion criteria: Coagulation disorders; any contraindication for Central Access catheterization.
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)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Postal code
Approval date
2015-04-16, 1394/01/27
Ethics committee reference number
105//449//د//94
Health conditions studied
1
Description of health condition studied
General symptoms and signs
ICD-10 code
R50
ICD-10 code description
Fever of other and unknown origin
2
Description of health condition studied
General symptoms and signs
ICD-10 code
R51
ICD-10 code description
Headache
3
Description of health condition studied
General symptoms and signs
ICD-10 code
R54
ICD-10 code description
Senility
4
Description of health condition studied
General symptoms and signs
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue
5
Description of health condition studied
General symptoms and signs
ICD-10 code
R55
ICD-10 code description
Syncope and collapse
6
Description of health condition studied
General symptoms and signs
ICD-10 code
R56
ICD-10 code description
Convulsions not elsewhere classified
7
Description of health condition studied
General symptoms and signs
ICD-10 code
R57
ICD-10 code description
Shock not elsewhere classified
8
Description of health condition studied
General symptoms and signs
ICD-10 code
R58
ICD-10 code description
Haemorrhage not elsewhere classified
9
Description of health condition studied
General symptoms and signs
ICD-10 code
R59
ICD-10 code description
Enlarged lymph nodes
10
Description of health condition studied
General symptoms and signs
ICD-10 code
R60
ICD-10 code description
Oedema not elsewhere classified
11
Description of health condition studied
General symptoms and signs
ICD-10 code
R61
ICD-10 code description
Hyperhidrosis
12
Description of health condition studied
General symptoms and signs
ICD-10 code
R62
ICD-10 code description
Lack of expected normal physiological development
13
Description of health condition studied
General symptoms and signs
ICD-10 code
R63
ICD-10 code description
Symptoms and signs concerning food and fluid intake
14
Description of health condition studied
General symptoms and signs
ICD-10 code
R64
ICD-10 code description
Cachexia
15
Description of health condition studied
General symptoms and signs
ICD-10 code
R65
ICD-10 code description
Systemic Inflammatory Response Syndrome
16
Description of health condition studied
General symptoms and signs
ICD-10 code
R68
ICD-10 code description
Other general symptoms and signs
17
Description of health condition studied
General symptoms and signs
ICD-10 code
R69
ICD-10 code description
Unknown and unspecified causes of morbidity
18
Description of health condition studied
General symptoms and signs
ICD-10 code
R52
ICD-10 code description
Pain not elsewhere classified
Primary outcomes
1
Description
Duration of Traditional CV-line Access
Timepoint
At the beginning of study
Method of measurement
Seconds
2
Description
Duration of ultrasonography-guided central intravenous access
Timepoint
At the beginning of study
Method of measurement
Seconds
Secondary outcomes
1
Description
Reason of using ultrasonography-guided central intravenous access
Timepoint
At the beginning of study
Method of measurement
Indication for CV line insertion
Intervention groups
1
Description
For other 50 patients, a central vein access will be inserted.
Category
Diagnosis
2
Description
For 50 patients, a central IV-line access will be inserted traditionally using landmarks.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Departement, Rasoul Akram hospital
Full name of responsible person
Farshid Farhadi, MD
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Eftekhar
Street address
Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farshid Farhadi,MD
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Hemat Highway
City
Tehran
Postal code
Phone
+98 21 4465 7807
Fax
Email
farshidfarhadi41@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Davood Farsi, MD
Position
Specialist of Emergency Medicine
Other areas of specialty/work
Street address
Iran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8860 2230
Fax
Email
davoodfa@2004yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farshid Farhadi, MD
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)