Clinical trial NCT02185664: Use of Static Ultrasound Guidance for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients
Official title: Comparison of the Landmark Technique and the Static Ultrasound Guided Technique for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Cardiac Surgical Patients
Keywords: internal jugular vein
landmark
ultrasound
static
cardiac surgery
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2014-07-09
Enrollment: 201
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Cannulation of the internal jugular vein (IJV) for central venous access is a standard practice in cardiac surgery. In this study, the authors tested the hypothesis that using an ultrasound (US) scanner would increase the success of IJV cannulation and decrease the incidence of complications in adult cardiac surgical patients.

The study will include adult cardiac surgical patients, randomized into two groups (control vs. US). In the control group, IJV cannulation will be performed by the conventional landmark technique using Seldinger method. In the US group, the course of the IJV will be marked before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The success rate, number of attempts, cannulation time and complication rate will be compared for the two groups.

Detailed description: Use of real time ultrasound has recently been recommended as the standard of care for insertion of central venous catheters. However, its usage is limited by various factors which include availability, space constraints and perceived lack of need according to surveys including cardiovascular anesthesiologists. We will conduct a prospective randomized controlled trial to compare the conventional landmark technique with the static ultrasound (US) technique that utilized the transthoracic echocardiography (TTE) ultrasound probe which is supplied along with the transesophageal echocardiography machines for internal jugular vein cannulation in adult cardiac surgical patients.

After ethical committee approval and patient consent, adult patients scheduled for elective cardiac surgery will be randomized to undergo internal jugular vein cannulation by either of the two methods: standard landmark technique (group A: control group), static US technique using the TTE probe (group B: ultrasound group). The success rate, number of attempts, total cannulation time and complication rate in the two groups will be compared.

Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for elective cardiac surgery

Exclusion Criteria:

* patients undergoing bidirectional Glenn shunt, Fontan surgery or emergency surgery
* local site infection
* presence of coagulopathy
* anatomical deformity of neck(burns, neck swelling, surgical scar)

Primary outcomes:
measure: success
timeFrame: during internal jugular venous cannulation
Secondary outcomes:
measure: number of attempts by finder/locator needle
timeFrame: at the time of internal jugular vein cannulation
measure: total number of attempts by puncture needle
timeFrame: at the time of internal jugular vein cannulation
measure: First attempt sucess
timeFrame: at the time of internal jugular vein cannulation
measure: Central venous cannulation time
timeFrame: at the time of internal jugular venous cannulation
measure: ultrasound time
timeFrame: at the time of internal jugular vein cannulation
measure: total cannulation time
timeFrame: at the time of internal jugular vein cannulation
measure: complication rate
timeFrame: at the time of central venous cannulation
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Anesthesia and Intensive Care, Govind Ballabh Pant Hospital
state: Delhi
Study officials:
affiliation: Govind Ballabh pant Hospital and Maulana azad Medical College, New Delhi, India
name: Deepak Tempe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Espinet A, Dunning J. Does ultrasound-guided central line insertion reduce complications and time to placement in elective patients undergoing cardiac surgery. Interact Cardiovasc Thorac Surg. 2004 Sep;3(3):523-7. doi: 10.1016/j.icvts.2004.05.006.
citation: Bailey PL, Glance LG, Eaton MP, Parshall B, McIntosh S. A survey of the use of ultrasound during central venous catheterization. Anesth Analg. 2007 Mar;104(3):491-7. doi: 10.1213/01.ane.0000255289.78333.c2.
citation: Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.