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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04840810
Other study ID # AgaKhanUH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date April 2, 2019

Study information

Verified date April 2021
Source Aga Khan University Hospital, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The insertion of central venous catheters (CVCs) has become an integral part of management of a critically ill patient. Access to the central vein may be required for the administration of hyper osmotic or vasoactive compounds, parenteral nutrition, and rapid infusion of large volumes of fluid or for the continuous or intermittent monitoring of biochemical or physiological parameters. Central venous catheter insertion is also indicated when the insertion of a peripheral line is not possible. Traditionally, CVC insertions have been performed using the landmark technique. Considering the number of CVCs being inserted every day, this can amount to a large number of complications. Efforts to minimize and prevent the occurrence of complications should be a routine component of quality improvement programs. There is an increasing body of evidence supporting the use of ultrasound guidance for CVC placement. This makes the strong rationale to conduct this research thus the aim of this study is to evaluate the real benefits i.e outcome of Long versus Short Axis ultrasound guided approach for internal jugular vein cannulation in the patient for elective cardiac surgery as central venous cannulation (CVC).


Description:

OBJECTIVE: To compare the in plane and out of plane ultrasound guided approach for internal jugular vein cannulation in the patients undergoing elective cardiac surgery. Ultrasound-guided central vein cannulation has many advantages, giving the operator the possibility of choosing the most appropriate and safest venous access on the basis of ultrasound assessment, performing a 100% safe insertion, ruling out malposition or pleuropulmonary damages, during and after the procedure. There is an increasing body of evidence supporting the use of ultrasound guidance for CVC placement. This makes the strong rationale to conduct this research thus the aim of this study is to evaluate the real benefits i.e outcome of Long versus Short Axis ultrasound guided approach for internal jugular vein cannulation in the patient for elective cardiac surgery as central venous cannulation (CVC).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 2, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients admitted for elective cardiac surgery. - Age between 18 - 75 years. Exclusion Criteria: - BMI more than 30. - Haemodynamically unstable. - Patient with abnormal coagulation profile(INR>1.5 or Platelet counts<50,000). - Patient with a short neck. - Patient with carotid Atherosclerosis proven on ultrasound.

Study Design


Intervention

Procedure:
In-plane Axis
In a long-axis view, the image plane is parallel to the course of the vessel (needle is "in-plane"). The image shows the course of the vessel across the screen and the shaft and point of the needle as it is advanced. The central venous cannulation was done in in-plane axis.
Out of plane Axis
In a short-axis view, the image plane is perpendicular to the course of the vessel and to the needle (needle is "out of plane"). The vessel appears as an anechoic circle on the screen of ultrasound with the needle visualized as a hyperechoic point in cross-section. The central venous cannulation was done in out of plane axis.

Locations

Country Name City State
Pakistan Aga khan university Hospital Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Jefferson P, Ogbue MN, Hamilton KE, Ball DR. A survey of the use of portable ultrasound for central vein cannulation on critical care units in the UK. Anaesthesia. 2002 Apr;57(4):365-8. — View Citation

Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. — View Citation

Schummer W, Schummer C, Rose N, Niesen WD, Sakka SG. Mechanical complications and malpositions of central venous cannulations by experienced operators. A prospective study of 1794 catheterizations in critically ill patients. Intensive Care Med. 2007 Jun;33(6):1055-9. Epub 2007 Mar 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary First pass success Rate Recoded in percentage. Needle successfully inserted into the internal jugular vein and there is no need of Readjustment immediately after end of procedure
Primary Duration of procedure Recorded in seconds Intraoperative (after skin prick to ultrasound confirmation of presence of guide wire within internal jugular vein)
Secondary Unintentional carotid puncture Recorded in percentage immediately after completion of procedure
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