| CTRI Number |
CTRI/2023/03/051215 [Registered on: 31/03/2023] Trial Registered Prospectively |
| Last Modified On: |
29/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of spinal mannequin based teaching with conventional teaching for spinal anesthesia. |
|
Scientific Title of Study
|
Comparison of spinal mannequin based simulation teaching with conventional didactic method of teaching subarachnoid block in novices: A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepanshu Dang |
| Designation |
Senior resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of anesthesiology and critical care , 3rd floor, emergency building, AIIMS Jodhpur Basni industrial area Jodhpur RAJASTHAN 342005 India |
| Phone |
9820879556 |
| Fax |
|
| Email |
dangdeepanshu94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Tanvi Meshram |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of anesthesiology and critical care, 3rd floor emergency building, AIIMS Jodhpur Basni industrial area Jodhpur RAJASTHAN 342005 India |
| Phone |
|
| Fax |
|
| Email |
tanvimeshram162@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Tanvi Meshram |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of anesthesiology and critical care, 3rd floor, emergency building, AIIMS Jodhpur Basni industrial area Jodhpur RAJASTHAN 342005 India |
| Phone |
|
| Fax |
|
| Email |
tanvimeshram162@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology and critical care,AIIMS Jodhpur |
|
|
Primary Sponsor
|
| Name |
Deepanshu Dang |
| Address |
AIIMS, Jodhpur |
| Type of Sponsor |
Other [Principal investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepanshu Dang |
AIIMS Jodhpur |
Department of anesthesiology and critical care,3rd floor emergency building, AIIMS ,Basni industrial area, 342005 Jodhpur RAJASTHAN |
9820879556
dangdeepanshu94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Jodhpur Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional |
Participants not trained on spinal mannequin but only recieved didactic teaching. |
| Intervention |
simulated Training |
participants who are trained on spinal mannequin. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Novice post graduate students of Anaesthesiology |
|
| ExclusionCriteria |
| Details |
Those who have previously observed or trained in neuraxial anaesthesia,or are not willing,or does not want to be assessed, will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| number of successful first attempt of spinal needle placement into subarachnoid space. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare total number of attempts for successful spinal needle placement
2.To compare number of needle-bone contacts
3.To compare ease of landmark palpation of space using Likert scale
4.To compare time taken to successfully perform subarachnoid block
5.To compare complications (dural puncture , vasovagal shock ,Bloody tap),
6.To compare able to appreciate give away/loss of resistance |
baseline |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
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 - .
|
|
Brief Summary
|
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. |