Indigenously Developed Ultrasound Phantom Model

NCT04527120 | Completed

• 1 other identifier: 03/19/IEC/JMMC&RI
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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?

Conditions

Simulation Training

Keywords

ultrasonography; vascular access; phantom model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Confidence in performing and teaching ultrasound guided vascular access using in plane approach

  6 hours

• Confidence in performing and teaching ultrasound guided vascular access using out of plane approach

  6 hours

Other Outcomes (1)

• Time taken to visualise needle tip and time taken to puncture vessel and draw fluid in out of plane approach and in plane approach

  6 hours

Study Arms (2)

Model A first and then B

OTHER

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)

Model B first and then A

OTHER

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)

Interventions

indigenously developed ultrasound phantom (IDUP) OTHER

Ultrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access.

Also known as: Jubilee Phantom

Model A first and then B; Model B first and then A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead
• All India Institute of Medical Sciences: collaborator

Study Sites (1)

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, 680005, India

Location

Study Officials

• Vimal Krishanan S, MD

  Manipal Academy of Higher education

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The examiners, examinees and statistician would be blinded to the nature of the model. The model would be matched in colour shape and size with the commercially available model. The models would be covered by a plastic surgical drape, with a label on top that said model A or model B. The models identity would be known only to the team leader. One the coin toss is complete and model allocated, the allocation would be marked unto a sealed envelope which would be opened only after data entry and analysis. Any untoward event needing unmasking of the models like damage to the model, warranting replacement was also carried out by the team leader.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in the department of Emergency Medicine

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: August 26, 2020
• Study Start: January 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: July 10, 2020
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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
• Access Criteria: google drive link would be shared

Locations

IN (1)