Skip to main content
Clinical Trials/CTRI/2018/12/016762
CTRI/2018/12/016762
Completed
Not Applicable

Influence of operator characteristics and different approaches on successful ultrasound guided central venous cannulation in paediatric patients

Department of Paediatric Anaesthesia1 site in 1 country120 target enrollmentStarted: January 1, 2019Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Department of Paediatric Anaesthesia
Enrollment
120
Locations
1
Primary Endpoint
To compare operator characteristics including anaesthesiologist experience, experience in paediatric anaesthesia, experience in paediatric central lines, experience in ultrasound guided lines and experience in a particular approach to central venous cannulation with success rate of line placement

Overview

Brief Summary

Central venous cannulation remains a mainstay procedure used in the treatment of critically ill patients as well as patients coming for major surgeries. Ultrasound guidance has improved the safety level of this procedure. However, successful line placement would vary between different operators with different experience as well as different approaches. The exact nature of these differences is unclear and yet to be defined in the paediatric population. Understanding the nature of these relationships can help define practices which would further enhance the safety and success rate of this procedure.

So the aim of this study would be to investigate the various operator related factors to different approaches of central venous cannulation in children below 12 years.

We want to include children below 12 years requiring central venous catheterisation under general anaesthesia. Children with any contraindication to central line placement such as coagulopathy, platelet count <50,000/mm3, on antiplatelet or anticoagulant medications would be excluded.

It will be a prospective analytical study for a period of 1 year. Written informed consent will be obtained prior to the procedure from the parents. Different operators (with more than 3 years experience in anaesthesiology and who have placed more than 50 central lines) would perform central venous cannulation. Selection of operators and approach would be non-randomised and depend on the consultant anaesthesiologist and operator themselves.The primary outcome measure would be to compare operator characteristics like anaesthesiologist experience, experience in paediatric anaesthesia, experience in paediatric central lines, experience in ultrasound guided lines and experience in a particular approach to central venous cannulation with respect to success rate of line placement, number of attempts, time taken for line placement and complications. Secondary outcomes would be to compare different approaches to central venous cannulation with respect to success rate, number of attempts, complications, time for cannulation as well as to compare success rate, number of attempts, complications, time for cannulation with respect to patient age, weight, as well as anaesthetic technique. The SPSS 24.0. software will used for statistical analysis of data of this study. Chi-square test will be used to test the association of different study variables and t-test will used to compare the means. Significance level will set at ≤0.05.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Day(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Paediatric patients less than 12 years requiring central venous catheterisation under general anaesthesia.

Exclusion Criteria

  • Children with any contraindication to central line placement such as coagulopathy, platelet count <50,000/mm3, on antiplatelet or anticoagulant medications.

Outcomes

Primary Outcomes

To compare operator characteristics including anaesthesiologist experience, experience in paediatric anaesthesia, experience in paediatric central lines, experience in ultrasound guided lines and experience in a particular approach to central venous cannulation with success rate of line placement

Time Frame: After guidewire insertion

Secondary Outcomes

  • To compare various operator characteristics with respect to number of attempts, complications and time required for central venous cannulation(After guidewire insertion)

Investigators

Sponsor
Department of Paediatric Anaesthesia
Sponsor Class
Government medical college

Study Sites (1)

Loading locations...

Similar Trials