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

Sponsor
Aga Khan University Hospital, Pakistan (Other)
Overall Status
Completed
CT.gov ID
NCT04840810
Collaborator
(none)
80
1
2
3
26.8

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: In-plane Axis
  • Procedure: Out of plane Axis
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
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.
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Mar 30, 2019
Actual Study Completion Date :
Apr 2, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. First pass success Rate [immediately after end of procedure]

    Recoded in percentage. Needle successfully inserted into the internal jugular vein and there is no need of Readjustment

  2. Duration of procedure [Intraoperative (after skin prick to ultrasound confirmation of presence of guide wire within internal jugular vein)]

    Recorded in seconds

Secondary Outcome Measures

  1. Unintentional carotid puncture [immediately after completion of procedure]

    Recorded in percentage

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aga khan university Hospital Karachi Sindh Pakistan

Sponsors and Collaborators

  • Aga Khan University Hospital, Pakistan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rizwana Shehzad, Staff Medical officer AKUH, Aga Khan University Hospital, Pakistan
ClinicalTrials.gov Identifier:
NCT04840810
Other Study ID Numbers:
  • AgaKhanUH
First Posted:
Apr 12, 2021
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 13, 2021