Clinical trial NCT03130660: Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations
Official title: Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations: A Prospective Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography
Central Line Complication
Keywords: central line
Central Line Complication
Lead sponsor: Institute of Medical Sciences and SUM Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patient to be randomized to two groups
Primary purpose: PREVENTION

Brief summary: We plan to compare single person short axis view with two person long axis view

Detailed description: Introduction: The guidelines for the use of bedside ultrasonography in the evaluation of critically ill patients published by the society of critical care medicine recommends short-axis view be used during insertion of central venous catheter (CVC) in internal jugular vein (IJV) to improve success rate1. The long axis view is considered better for cannulations as it helps in preventing posterior wall puncture but in the trials it has been found to be inconvenient for a single user2,3. We hypothesise that if two persons perform long axis cannulations i.e. one person will image the vein while the other punctures it will be equally convenient to single person doing the cannulations in short axis. The advantage we expect to see is lesser complications in long axis group.

Methodology:

Inclusion criteria: Any patient getting admitted to ICU and requiring central venous cannulations.

Exclusion: Lack of consent. Randomization: At a 1:1 ratio, to be achieved using a computer-generated random number sequence for 100 consecutive subjects Study intervention: Eligible patients will be randomized to a short-axis or long axis technique for ultrasound guided IJV cannulations. Ultrasound guidance will be performed dynamically using a single-operator technique for short axis and double operator technique for long axis view. Cannulations and USG is to be carried out by 2 trained Anaesthesiologists.

Definition:

1. Insertion time: Time taken from 1st puncture of skin to insertion of guide wire into the vein.
2. Total Procedure time: Time from when Ultrasound scan was started to complete suturing of the CVC line.
3. Number of needle sticks: Number of time punctures were done in the skin. Complications were noted as hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax.

All the times are to be noted by a bedside nurse who is not involved in the trial or knows the study hypothesis.

Statistical Analysis: An intention-to-treat analysis was performed. Insertion time, overall procedure time and number of needle sticks, and will be compared using Mann-Whitney U tests. The success rate and complication rate will be compared using Fisher exact tests. All statistical analyses will be performed with SPSS 20.0

Eligibility criteria: Inclusion Criteria:

* Any patient getting admitted to ICU and requiring central venous cannulations.

Exclusion Criteria:

* Lack of consent

Primary outcomes:
measure: time to insertion
timeFrame: 15 minutes
Secondary outcomes:
measure: Total Procedure time
timeFrame: 15 minutes
measure: Number of needle sticks
timeFrame: 15 minutes
measure: Complications
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: IMS and SUM Hospital
state: Odisha
Study officials:
affiliation: IMS and Sum hospital
name: Arun Rath, MD
role: STUDY_DIRECTOR
References: