NCT05387486

Brief Summary

Investigator compared three techniques of Central venous cannulation (CVC) insertion, Anatomical Landmark, Pre-location Ultrasound and the Real Ultrasound techniques, in cardiac surgical patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration 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

August 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

May 19, 2022

Last Update Submit

July 30, 2023

Conditions

Catheterization, Central Venous

Keywords

Cardiac SurgeryCentral Venous CatheterAnatomical LandmarkUltrasound

Outcome Measures

Primary Outcomes (1)

  • Success Rate

    Success rate will be measured according to the number of attempts. The cannulation of right Internal Jugular Vein within the first three attempts.

    Day 1

Secondary Outcomes (2)

  • Time duration for each technique

    Day 1

  • Incidence of Complications

    Day 1

Study Arms (3)

ALT

ACTIVE COMPARATOR
Procedure: Anatomical Landmark technique

USG-Pre

ACTIVE COMPARATOR
Procedure: Ultrasound-guided pre location technique

USG -RT

ACTIVE COMPARATOR
Procedure: Ultrasound-guided real-time technique

Interventions

Anatomical Landmark techniquePROCEDURE

anatomical landmarks (sternocleidomastoid muscles, sternal notch, cricoid cartilage, carotid artery and clavicle) will be palpated. A 3cc syringe with 21 gauge needle (locator) will be used first to locate IJV at the apex of the triangle formed by the two heads of the sternocleidomastoid muscle. After successful location, an introducer needle of 18 gauge, attached with a 5 ml syringe, will be inserted at the same point. The introducer needle will be directed towards the ipsilateral nipple at an angle of 20-30° with the skin

ALT
Ultrasound-guided pre location techniquePROCEDURE

In Group Ultrasound-guided pre location technique, venipuncture site will be determined using ultrasound probe which will be then removed and locator needle of 21 gauge will be used first to confirm IJV location. The cannulation or venipuncture will be performed at the marked point of locator needle by the use of 18 gauge introducer needle.

USG-Pre
Ultrasound-guided real-time techniquePROCEDURE

In Group Ultrasound-guided real-time technique, cannulation or venipuncture will be performed under real-time imaging using 18 gauge needle i-e ultrasound will be used for prelocation and puncturing of IJV and locator needle will not be used

USG -RT

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years
  • ASA (American society of Anesthesiologists) status 1 to 3 requiring central venous catheter during surgical procedure
  • ASA (American society of Anesthesiologists) status 4 patients coming for cardiac surgery

You may not qualify if:

  • Patients with a history of following
  • Previous head and neck surgery
  • Head and neck mass or cancer.
  • Superior vena cava syndrome.
  • Coagulopathy.
  • Infection at the cannulation site.
  • Previous central venous access.
  • Anatomical Changes due to surgery or any pathology in the neck which can lead to distortion of anatomical land marks in the region of puncture.
  • Raised intracranial pressure (ICP).
  • Patients coming for emergency surgery
  • Patients with BMI (Body Mass Index) more than 30
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University hospital

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (3)

  • Ray BR, Mohan VK, Kashyap L, Shende D, Darlong VM, Pandey RK. Internal jugular vein cannulation: A comparison of three techniques. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):367-71. doi: 10.4103/0970-9185.117115.

    PMID: 24106363BACKGROUND

  • Leung J, Duffy M, Finckh A. Real-time ultrasonographically-guided internal jugular vein catheterization in the emergency department increases success rates and reduces complications: a randomized, prospective study. Ann Emerg Med. 2006 Nov;48(5):540-7. doi: 10.1016/j.annemergmed.2006.01.011. Epub 2006 Feb 21.

    PMID: 17052555BACKGROUND

  • Kaye AD, Fox CJ, Hymel BJ, Gayle JA, Hawney HA, Bawcom BA, Cotter TD. The importance of training for ultrasound guidance in central vein catheterization. Middle East J Anaesthesiol. 2011 Feb;21(1):61-6.

    PMID: 21991734BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 24, 2022

Study Start

August 1, 2019

Primary Completion

April 1, 2021

Study Completion

July 4, 2021

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)