Indigenously Developed Ultrasound Phantom Model

Study Overview
=================
Brief Summary
-----------------
Point of care ultrasound (POCUS) is used ever more increasingly across the emergency medicine departments in India. Guided procedures like nerve blocks, vascular access, abscess drainage and foreign body exploration are done more conveniently and efficiently utilising visualisation under ultra sonography. Several training models are available commercially that aids in training the novice and expert in the field alike. The commercially available models are expensive and inaccessible for most, while the utility of POCUS in Emergency Department (ED) is on the rise. This has lead people to experiment with various models for training which ranges from basic gelatin moulds to ballistic gel. There are only a few studies that compare these with the commercially available products for educational purposes. The home made models are cheaper and more easily procurable for training making it a relatively favourable choice in financially constrained situations. The investigators have been using a gelatine based training model to train their emergency medicine residents for many years. In this study they intend to assess whether their indigenously developed ultrasound phantom model is comparable to commercially available models for vascular access training.They also sought to assess the better preliminary teaching model for ultrasound guided vascular access: in-plane or out-of-plane approach?

Official Title
-----------------
Indigenously Developed Ultrasound Phantom Model vs a Commercially Available Training Model: a Randomised Triple Blind Study

Conditions
-----------------
Simulation Training

Intervention / Treatment
-----------------
* Other: indigenously developed ultrasound phantom (IDUP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All the participants of the ultrasound training module who underwent the vascular access course were considered eligible to participate if they consented for the study Exclusion Criteria: - Participants of the ultrasound training module who underwent the vascular access course not giving consent to participate or Participant ultrasound training module who underwent the vascular access course withdrawing consent for using the data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Model A first and then B<br>Model A and B would be randomly allotted to commercial model and IDUP. Intervention limb would involve performing on sequentially on the commercial and IDUP, following which a feed back of the candidates would be recorded about their performance on the same with respect to sonological appearance, tactile feedback, artefacts and ease of performing the procedure. Set time points (time to needle tip visualisation, time to puncture) and no of attempts before successful cannulation would be recorded by an assessor on a pre set proforma. | Other: indigenously developed ultrasound phantom (IDUP)<br>* Ultrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access.<br>* Other names: Jubilee Phantom;|
| Other: Model B first and then A<br>Model A and B would be randomly allotted to commercial model and IDUP. Intervention limb would involve performing on sequentially on the commercial and IDUP, following which a feed back of the candidates would be recorded about their performance on the same with respect to sonological appearance, tactile feedback, artefacts and ease of performing the procedure. Set time points (time to needle tip visualisation, time to puncture) and no of attempts before successful cannulation would be recorded by an assessor on a pre set proforma. | Other: indigenously developed ultrasound phantom (IDUP)<br>* Ultrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access.<br>* Other names: Jubilee Phantom;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative scoring of the two ultrasound phantom models | Comparison of the two ultrasound model assessed on a five point Likert scale (1- worst score, 5- best score) in terms of resemblance, tactile feed back, artefacts and ease of use done at the end of the study. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confidence in performing and teaching ultrasound guided vascular access using in plane approach | Post workshop confidence level change in performing and teaching needle tracking and vascular access, with in plane approach, assessed on a five point Likert scale (1- least confident score, 5- most confident) | 6 hours | 
| Confidence in performing and teaching ultrasound guided vascular access using out of plane approach | Post workshop confidence level change in performing and teaching needle tracking and vascular access, with out of plane approach, assessed on a five point Likert scale (1- least confident score, 5- most confident) | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasonography, vascular access, phantom model