Simulation TrainingIDUPNCT04527120
Indigenously Developed Ultrasound Phantom Model
A study testing indigenously developed ultrasound phantom (IDUP) in people with Simulation Training, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulation Training
- What is being tested?
- indigenously developed ultrasound phantom (IDUP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2018to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, 680005
About this study
Official title: 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.
Read more
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
- Being tested
- indigenously developed ultrasound phantom (IDUP)
- Keywords
- ultrasonography, vascular access, phantom model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indigenously developed ultrasound phantom (IDUP)Other
Also called Jubilee Phantom
Ultrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: indigenously developed ultrasound phantom (IDUP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (2)
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)
Measured: 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)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Jan 2018
- Primary completion30 Jun 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences
- Responsible party
- Principal investigator, Siju V Abraham, MD, Jubilee Mission Medical College and Research Institute
- Investigators
- Vimal Krishanan S, MD, Study director, Manipal Academy of Higher education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527120
- Sponsor's protocol ID
- 03/19/IEC/JMMC&RI
- Acronym
- IDUP
- Status last verified
- Sep 2020
- First submitted
- 25 Jul 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data abstracted would be shared as excel sheet. The study protocol also would be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indigenously Developed Ultrasound Phantom Model vs a Commercially Available Training Model: a Randomised Triple Blind Study
- ClinicalTrials.gov ID
- NCT04527120
- Acronym / sponsor ID
- IDUP / 03/19/IEC/JMMC&RI
- Conditions
- Simulation Training
- Keywords
- ultrasonography, vascular access, phantom model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model A first and then B | Other | Other: indigenously developed ultrasound phantom (IDUP)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. |
| Model B first and then A | Other | Other: indigenously developed ultrasound phantom (IDUP)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indigenously developed ultrasound phantom (IDUP)Also: Jubilee PhantomUltrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access. | Other | Model A first and then B, Model B first and then A |
Primary outcome
Comparative scoring of the two ultrasound phantom models
Time frame: 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.
2 secondary outcomes
Confidence in performing and teaching ultrasound guided vascular access using in plane approach
Time frame: 6 hours
Confidence in performing and teaching ultrasound guided vascular access using out of plane approach
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: Yes. Participant data abstracted would be shared as excel sheet. The study protocol also would be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vimal Krishanan S, MD study director
Manipal Academy of Higher education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing indigenously developed ultrasound phantom (IDUP) in people with Simulation Training, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative scoring of the two ultrasound phantom models (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.