NCT04840810

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 8, 2021

Last Update Submit

April 12, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Unintentional carotid puncture

    immediately after completion of procedure

Study Arms (2)

Out of plane/ short axis central venous cannulation

ACTIVE COMPARATOR

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-plane/long axis central venous cannulation

ACTIVE COMPARATOR

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

Interventions

In-plane AxisPROCEDURE

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/ 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.

In-plane/long axis central venous cannulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted for elective cardiac surgery.
  • Age between 18 - 75 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga khan university Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 17342519BACKGROUND
  • 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.

    PMID: 11939995BACKGROUND
  • 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.

    PMID: 8968276BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Medical officer AKUH

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 12, 2021

Study Start

January 1, 2019

Primary Completion

March 30, 2019

Study Completion

April 2, 2019

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations