Indigenously Developed Ultrasound Phantom Model

Simulation Training Clinical Trial

— IDUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527120
• Other study ID #: 03/19/IEC/JMMC&RI
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 10, 2020

Study information

• Verified date: September 2020
• Source: Jubilee Mission Medical College and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 10, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Simulation Training

Intervention

Other:
• indigenously developed ultrasound phantom (IDUP)
Ultrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access.

Locations

Country	Name	City	State
India	Jubilee Mission Medical College and Research Institute	Thrissur	Kerala

Sponsors (2)

Lead Sponsor	Collaborator
Jubilee Mission Medical College and Research Institute	All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time taken to visualise needle tip and time taken to puncture vessel and draw fluid in out of plane approach and in plane approach	Time taken to sonologically visualise the cannulating needles tip and time taken to puncture vessel and aspirate fluid in out of plane approach and in plane approach measured in seconds	6 hours
Primary	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	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
Secondary	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