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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05387486
Other study ID # 3488-Ane-ERC-15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date July 4, 2021

Study information

Verified date July 2023
Source Aga Khan University Hospital, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Central venous cannulation (CVC) is the cannulation of a large central vein in neck (internal jugular vein), chest (subclavian or axillary) or groin (femoral vein). It is a standard clinical method performed for the monitoring of central venous pressure, temporary haemodialysis, drug administration (drugs irritating peripheral veins, chemotherapy, concentrated vasoactive drugs ) rapid infusion of fluids, inadequate peripheral intravenous access and sampling site for repeated blood sampling. There are different techniques for Central venous cannulation which include anatomical landmark and ultrasound guided (USG) technique. Previous studies have shown that the successful IJV cannulation using anatomical landmark technique was 85% as compared to ultrasound guided IJV cannulation which was 95%.The median catheterisation time of internal jugular vein via ultrasound guided (USG) is shorter than anatomical landmark technique. There has been little evidence regarding the use of ultrasound guidance for internal jugular vein cannulation at a tertiary care hospital in our population. Furthermore with widespread availability of ultrasound, Internal Jugular vein can be successfully cannulated with decreasing number of attempts, less time consumption and decrease in the incidence of complications.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date July 4, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Anatomical Landmark technique
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
Ultrasound-guided pre location technique
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.
Ultrasound-guided real-time technique
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

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)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time duration for each technique Measurment of time in minutes Day 1
Secondary Incidence of Complications Look for carotid puncture, haematoma formation , pneumothorax Day 1
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