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临床试验/NCT04527120
NCT04527120已完成不适用

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

Jubilee Mission Medical College and Research Institute2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Comparative scoring of the two ultrasound phantom models

研究概览

简要总结

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?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Comparative scoring of the two ultrasound phantom models

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Jubilee Mission Medical College and Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Siju V Abraham, MD

Associate Professor in the department of Emergency Medicine

Jubilee Mission Medical College and Research Institute

研究点 (2)

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