Protocol summary

Summary
We sought to determine if the use of a static ultrasound technique could, a) allow clinicians to visualize peripheral veins and b) improve success rates of peripheral venous cannulation in young children in the pediatric patients. We will perform a randomized clinical trial of 70 children less than 5 years old by physical status with ASA I and ASA II in an academic pediatric hospital who will be required IV access. We’ll be randomized patients to either continued standard IV attempts. In the ultrasound group , great saphenous vein localization will be performed by a physician. patients who had multiple attempts to iv accessing or had scar in iv access localization will be excluded. Intravenous cannulation attempts will be performed by the anesthesiologist who have transverse view on target vessel location by ultrasonography. In second group intravenous cannulation attempts will be performed by the same anesthesiologist who have direct view on anatomical signs for standard iv access. We will record success rate in first try. We will compare group success rates using differences in 95% confidence intervals.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201501304041N9
Registration date: 2015-04-23, 1394/02/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-04-23, 1394/02/03
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Uiniversity of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of peripheral venous cannulation success rate with ultrasonography or direct vision in children under 5 years
Public title
ultrasonography for peripheral venous cannulation
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : physical status with ASA I and ASA II ; age less than 5 years old ; candidate to surgery procedure less than 1 hour. exclusion criteria : patients who had multiple attempts to iv accessing ; had scar in iv access localization.
Age
To 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethic committee of university, Research Vice chancellor of Tabriz University of Medical Sciences , Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.Iran
City
Tabriz
Postal code
5166614711
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
931

Health conditions studied

1

Description of health condition studied
anesthesia for surgery
ICD-10 code
K40.2
ICD-10 code description
Bilateral inguinal hernia, without obstruction or gangrene

Primary outcomes

1

Description
success rate in first try
Timepoint
after success iv access
Method of measurement
questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
ultrasonography
Category
Treatment - Other

2

Description
classic method
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Alireza Hatami
Street address
Tabriz Children's Hospital, Sheshgelan street, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Golgasht Ave- Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Hatami
Position
student
Other areas of specialty/work
Street address
Tabriz Children Hospital,Sheshkelan,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3477 3957
Fax
Email
alireza.hatami.1990@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Seyedhejazi
Position
Professor
Other areas of specialty/work
Street address
Tabriz Children Hospital,Sheshkelan,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3477 3957
Fax
Email
seidhejazie@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Seyedhejazi
Position
Professor
Other areas of specialty/work
Street address
Tabriz Children Hospital,Sheshkelan,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3477 3957
Fax
Email
seidhejazie@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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