Comparison of the complications of inter and post operation of central vein catheterization (CVC) of internal jugular vein in repaired and cut down method in neonates
Goal: to compare the complications of inter and post operation of central vein catheterization (CVC) of internal jugular vein in repaired and cut down methods in 71 Neonates under 30 days. In repair method cases were positioned in trendelenburg (30 degree) position. After fixing the head in a hyper extended position, it was turned to the left. Catheterization was done using a luminal broviac catheter (14-16 G) under anesthetic monitoring. After the local anesthesia (Lidocaine 1%) on Sternocleidomastoid (SCM) an incision (2 Cm) was made. Following the dissection of subcutaneous tissue and platysma muscle, the SCM was exposed. On the anterior Portion a space was made and internal Jugular vein below the muscle was identified. Using a silk Suture (3-0) both ends of vein was elevated. Then in the lateral Portion of the nipple (6-8 Cm from the incision) under the influence of local anesthesia a small incision was made and through a subcutaneous canal central venous canal (CVC) was moved to the neck region. Cutting on the vein, lateral side of the vein wall was opened to let the Catheter to move inside. Making an aspiration with a syringe provided the efficacy of the Catheter. The site of catheter cut was narrowed using a prolin suture (6-0) to prevent the bleeding. On termination, the Catheter was fixed on the skin and the site of catheterization was verified using a chest graphy. In cutdown method the procedure was the same with the exception that after the exposure of internal Jugular vein, at first the proximal side of the vein was ligated using a silk suture (3-0) and the Catheter was guided towards the distal lumen of internal Jugular vein and fixed on the skin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010241106N3
Registration date:2010-12-09, 1389/09/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-09, 1389/09/18
Registrant information
Name
Zohreh Azarbad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 2999
Email address
azarbad_zo@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kashan University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the complications of inter and post operation of central vein catheterization (CVC) of internal jugular vein in repaired and cut down method in neonates
Public title
Comparison of the complications of inter and post operation of central vein catheterization (CVC) of internal jugular vein in repaired and cut down method in neonates.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Neonates under 30 days with an indication of CVC. Exclusion criteria: Neonates with severe coagulatory disorders; Contraindicated for CVC; non-reluctant to follow-up and Doppler Sonography; failure and inability in catheterization.
Age
From 1 year old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
71
Randomization (investigator's opinion)
Not 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
Deputy of Research, Kashan University of Medical Sciences
Street address
5th kilometer of Ravand Road
City
Kashan
Postal code
8715988141
Approval date
2010-09-28, 1389/07/06
Ethics committee reference number
1919/1/5/29پ
Health conditions studied
1
Description of health condition studied
Lack of peripheral venous access
ICD-10 code
Y65
ICD-10 code description
Other misadventures during surgical and medical care
Primary outcomes
1
Description
success of central vein catheterization of internal jugular vein in cut down method
Timepoint
preioperation until end of admission
Method of measurement
Examination and Chest x-ray
Secondary outcomes
1
Description
bleeding
Timepoint
preioperation
Method of measurement
observation
2
Description
arterial perforation
Timepoint
preioperation
Method of measurement
observation
3
Description
hematoma
Timepoint
preioperation until 1 hour later
Method of measurement
observation
4
Description
obstruction in thoracic duct
Timepoint
preioperation until 72 hour later
Method of measurement
physical exam and X-ray
5
Description
emboli
Timepoint
preioperation
Method of measurement
observation
6
Description
hydrothorax
Timepoint
preioperation until 72 hour later
Method of measurement
vital sgin and chest x-ray
7
Description
Spontaneous withdrawal catheter
Timepoint
until 72 hours postoperative
Method of measurement
observation
8
Description
haemothorax
Timepoint
preioperation until 72 hour later
Method of measurement
vital sgin and chest x-ray
9
Description
Heart Arrhythmia
Timepoint
Intraoperative
Method of measurement
Heart monitoring
10
Description
pneumothroax
Timepoint
preioperation until 72 hour later
Method of measurement
vital sgin and chest x-ray
11
Description
Tamponade
Timepoint
preioperation until 72 hour later
Method of measurement
vital sgin and chest x-ray
12
Description
failure in catheter insertation
Timepoint
Intraoperative
Method of measurement
observation
13
Description
thrombosis
Timepoint
until 3 months postoperative
Method of measurement
Sonography Doppler
14
Description
Surgical site infections
Timepoint
until 72 hours postoperative
Method of measurement
Examination and culture samples
Intervention groups
1
Description
central vein catheterization of internal jugular vein in cut down method
Category
Treatment - Surgery
2
Description
central vein catheterization of internal jugular vein in repaired method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Dr. Mehrdad. Hosseinpoor
Street address
5th kilometer of Ravand Road
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
5th kilometer of Ravand Road
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Reza Mashhadi
Position
General Surgery Resident
Other areas of specialty/work
Street address
residential site of University
City
Kashan
Postal code
3515212527
Phone
+98 35 1521 2527
Fax
+98 36 1557 5057
Email
Meh_hosseinpoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Hosseinpoor
Position
Pediatric surgical specialty
Other areas of specialty/work
Street address
Beheshti Hospital, 5th Kilometer of Ravand Road
City
Kashan
Postal code
8715981151
Phone
+98 36 1555 0026
Fax
+98 36 1557 5057
Email
Meh_hosseinpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Hosseinpoor
Position
Pediatric surgical specialty
Other areas of specialty/work
Street address
Beheshti Hospital, 5th Kilometer of Ravand Road
City
Kashan
Postal code
8715981151
Phone
+98 36 1555 0026
Fax
+98 36 1557 5057
Email
Meh_hosseinpoor@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)