Indigenously Developed Ultrasound Phantom Model (IDUP)

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

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?

Study Overview

• Status: Completed
• Conditions: Simulation Training
• Intervention / Treatment: Other: indigenously developed ultrasound phantom (IDUP)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Kerala
    • Thrissur, Kerala, India, 680005
      • Jubilee Mission Medical College and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Model A first and then B; 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); Ultrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access.; Other Names: Jubilee Phantom
Other: Model B first and then A; 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); Ultrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access.; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jubilee Mission Medical College and Research Institute
• Collaborators: All India Institute of Medical Sciences, New Delhi
• Investigators: Study Director: Vimal Krishanan S, MD, Manipal Academy of Higher education

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: July 25, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: ultrasonography; vascular access; phantom model
• Other Study ID Numbers: 03/19/IEC/JMMC&RI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Participant data abstracted would be shared as excel sheet. The study protocol also would be shared
• IPD Sharing Time Frame: After publication of the results in a journal, the result would be accessible to all, for a duration no less than one year
• IPD Sharing Access Criteria: google drive link would be shared
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No