Clinical trial NCT04527120: Indigenously Developed Ultrasound Phantom Model
Official title: Indigenously Developed Ultrasound Phantom Model vs a Commercially Available Training Model: a Randomised Triple Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulation Training
Keywords: ultrasonography
vascular access
phantom model
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
First posted: 2020-08-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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?


Eligibility criteria: 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

Primary outcomes:
measure: Comparative scoring of the two ultrasound phantom models
timeFrame: 6 hours
Secondary outcomes:
measure: Confidence in performing and teaching ultrasound guided vascular access using in plane approach
timeFrame: 6 hours
measure: Confidence in performing and teaching ultrasound guided vascular access using out of plane approach
timeFrame: 6 hours
Other outcomes:
measure: Time taken to visualise needle tip and time taken to puncture vessel and draw fluid in out of plane approach and in plane approach
timeFrame: 6 hours
Locations:
city: Thrissur
country: India
facility: Jubilee Mission Medical College and Research Institute
state: Kerala
Study officials:
affiliation: Manipal Academy of Higher education
name: Vimal Krishanan S, MD
role: STUDY_DIRECTOR
References: