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Indigenously Developed Ultrasound Phantom Model

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04527120
Acronym
IDUP
Enrollment
48
Registered
2020-08-26
Start date
2018-01-01
Completion date
2020-07-10
Last updated
2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simulation Training

Keywords

ultrasonography, vascular access, phantom model

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?

Interventions

OTHERindigenously developed ultrasound phantom (IDUP)

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

Sponsors

All India Institute of Medical Sciences
CollaboratorOTHER
Jubilee Mission Medical College and Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Comparative scoring of the two ultrasound phantom models6 hoursComparison 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

MeasureTime frameDescription
Confidence in performing and teaching ultrasound guided vascular access using in plane approach6 hoursPost 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)
Confidence in performing and teaching ultrasound guided vascular access using out of plane approach6 hoursPost 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

MeasureTime frameDescription
Time taken to visualise needle tip and time taken to puncture vessel and draw fluid in out of plane approach and in plane approach6 hoursTime 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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026