跳至主要内容
临床试验/CTRI/2023/03/051215
CTRI/2023/03/051215尚未招募2 期

Comparison of spinal mannequin based simulation teaching with conventional didactic method of teaching subarachnoid block in novices: A randomised controlled trial

Deepanshu Dang1 个研究点 分布在 1 个国家入组 50 人开始时间: 2023年10月4日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
number of successful first attempt of spinal needle placement into subarachnoid space.

研究概览

简要总结

Neuraxial anaesthesia is the standard and reliable technique of intraoperative and postoperative pain relief for patients undergoing surgeries.Neuraxial anaesthesia is difficult to learn and takes many years to attain expertise. [1] The evidence for teaching the skills and knowledge necessary to be competent and safe in neuraxial anaesthesia is limited, despite clinical acceptance of the technique. United Kingdom department of health recommended that health professional should learn skills in simulation environment before undertaking them in supervised clinical practice. [2]Invitro models provide novice safe medium to correct errors, gain motor skills and allow time to develop proficiency before undertaking procedures on patients. Many types of phantoms are available including water, tofu, beef gravy, gelatin, elastomeric rubber, turkey, beef, pork and fresh and embalmed cadavers. Each of these models has advantages and disadvantages in terms of fidelity, cost and availability.[3]The transformation from an unstructured and unsystematic approach to a more structured approach to teach procedural skills is much needed ,it is unethical for novices at any level of training to practice new skills on patients even if they have patients explicit consent. There are fewer opportunities to learn on patients due to a decreased tolerance for medical error and increased reluctance to accept risk to patients from learners. The ethics of learning on patients with inanimate alternatives are readily available, and hence exposing both patient and learner to avoidable risk. [4]In a study by Vander Wielen et al. , participants who viewed a brief instructional video  improved their ability to acquire ultrasound images and identify anatomical landmarks on a live model. However, a group randomized to a hands-on training session with an anatomy-based gel phantom (scanning session did not exceed ten minutes) was more successful than the video group in identifying anatomical landmarks when both were compared to a control group, reinforcing the value of handson experience and dynamic image interpretation to learn sonoanatomy.[5]Conventional didactic methods of learning where anaesthesia residents after observing a specific number of procedures under educator guidance when tried to perform the procedures faced many difficulties and their success dependent on many technical and non-technical factors. Performing neuraxial anaesthesia by conventional observational methods can be technically difficult and demand some amount of expertise and experience. Relying on individuals limited experience alone can lead to incorrect identification of the targeted epidural space.furthermore, without knowledge of anatomy and correct interpretation of sonoanatomy, novices can fail to recognize abnormal anatomy and may endanger patients with inadvertent dural puncture. This may also result in increased procedural time, multiple needle passes, unstable needle movements, patient discomfort and inadequate neuraxial blockade. Simulated training can be a valuable tool for acquiring knowledge and skills, gaining hands-on experience through repetitive practice of salient aspects of a procedure and provide some sensory feedback without harm to patients, and receiving individualized feedback. Declining learning opportunities in clinical practice and the need to maximize patient  safety dictate that cognitive and integrative stage should occur before learners practice on patients. [7]One area of uncertainty is the choice of the best model or phantom to teach ultrasoundâ€guided neuraxial anaesthesia technical skills. The rationale for training using inâ€vitro models is to provide novices with a safe medium to correct errors, gain motor skills and allow time to develop proficiency before undertaking procedures on patients. Lots of efforts are ongoing in examining the different components of the UGRA and many teaching methods have been used without fully researching their effectiveness. Only few studies are available on head to head comparison on different teaching models. Hence, we designed this study to determine if there was any advantage in using blue phantom spinal epidural model when training novices to perform neuraxial anaesthesia.

研究设计

研究类型
干预性
分配方式
随机
随机化方法
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Novice post graduate students of Anaesthesiology.

排除标准

  • Those who have previously observed or trained in neuraxial anaesthesia,or are not willing,or does not want to be assessed, will be excluded.

结局指标

主要结局

number of successful first attempt of spinal needle placement into subarachnoid space.

时间窗: baseline

次要结局

  • 1.To compare total number of attempts for successful spinal needle placement(2.To compare number of needle-bone contacts)

研究者

发起方
Deepanshu Dang
申办方类型
Other [Principal investigator]

研究点 (1)

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标识符

CTRI 编号
CTRI/2023/03/051215

日期

最近更新
(3年前)

监管与共享

个体参与者数据共享计划
是

Will individual participant data (IPD) be shared publicly (including data dictionaries)?   Response  - YES What data in particular will be shared? Response  - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices). What additional supporting information will be shared? Response  -  Study Protocol Response  - Informed Consent Form Response  - Clinical Study Report Who will be able to view these files? Response  - Anyone For what types of analyses will this data be available? Response  - To achieve aims in the approved proposal. By what mechanism will data be made available? Response  - Proposals should be directed to [ dangdeepanshu94@gmail.com ]. For how long will this data be available start date provided 31-03-2024 and end date provided 30-03-2025 ? Response  - Immediately following publication. No end date. Any URL or additional information regarding plan/policy for sharing IPD?  Additional Information  - .

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