IDUP: Indigenously Developed Ultrasound Phantom Model

Sponsor
Jubilee Mission Medical College and Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04527120
Collaborator
All India Institute of Medical Sciences, New Delhi (Other)
48
1
2
30.3
1.6

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: indigenously developed ultrasound phantom (IDUP)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Other
Official Title:
Indigenously Developed Ultrasound Phantom Model vs a Commercially Available Training Model: a Randomised Triple Blind Study
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jul 10, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Comparative scoring of the two ultrasound phantom models [6 hours]

      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.

    Secondary Outcome Measures

    1. Confidence in performing and teaching ultrasound guided vascular access using in plane approach [6 hours]

      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)

    2. Confidence in performing and teaching ultrasound guided vascular access using out of plane approach [6 hours]

      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)

    Other Outcome Measures

    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]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jubilee Mission Medical College and Research Institute Thrissur Kerala India 680005

    Sponsors and Collaborators

    • Jubilee Mission Medical College and Research Institute
    • All India Institute of Medical Sciences, New Delhi

    Investigators

    • Study Director: Vimal Krishanan S, MD, Manipal Academy of Higher education

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Siju V Abraham, MD, Associate Professor in the department of Emergency Medicine, Jubilee Mission Medical College and Research Institute
    ClinicalTrials.gov Identifier:
    NCT04527120
    Other Study ID Numbers:
    • 03/19/IEC/JMMC&RI
    First Posted:
    Aug 26, 2020
    Last Update Posted:
    Oct 1, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Siju V Abraham, MD, Associate Professor in the department of Emergency Medicine, Jubilee Mission Medical College and Research Institute

    Study Results

    No Results Posted as of Oct 1, 2020