To Compare the In-plane and Out of Plane Ultrasound Guided Approach for Internal Jugular Vein Cannulation in the Patients Undergoing Elective Cardiac Surgery.

To Compare the In-plane and Out of Plane Ultrasound Guided Approach for Internal Jugular Vein Cannulation in the Patients Undergoing Elective Cardiac Surgery. A Prospective Randomize Control Trial.

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).

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Cardiac Surgical Procedures; Catheterization, Central Venous
• Intervention / Treatment: Procedure: In-plane Axis; Procedure: Out of plane Axis

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Aga Khan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Out of plane/ short axis central venous cannulation; 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.	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.
ACTIVE_COMPARATOR: In-plane/long axis central venous cannulation; 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of procedure	Recorded in seconds	Intraoperative (after skin prick to ultrasound confirmation of presence of guide wire within internal jugular vein)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unintentional carotid puncture	Recorded in percentage	immediately after completion of procedure

Collaborators and Investigators

• Sponsor: Aga Khan University Hospital, Pakistan

Publications and helpful links

General Publications

• 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. doi: 10.1007/s00134-007-0560-z. Epub 2007 Mar 7.
• 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. doi: 10.1046/j.1365-2044.2002.02319.x.
• 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. doi: 10.1097/00003246-199612000-00020.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): April 2, 2019

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (ACTUAL): April 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AgaKhanUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No