| CTRI Number |
CTRI/2022/08/044725 [Registered on: 17/08/2022] Trial Registered Prospectively |
| Last Modified On: |
13/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Comparing traditional versus simulation teaching in basic trans-thoracic echocardiography |
|
Scientific Title of Study
|
Simulation with point of care teaching versus conventional point of care teaching in basic trans-thoracic echocardiography - a randomised controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayesha Goyal |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Cardiac Anaesthesia
AIIMS Rishikesh
Rishikesh
Dehradun UTTARANCHAL 249201 India |
| Phone |
9741587051 |
| Fax |
|
| Email |
ayesha.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Dept of Cardiac Anaesthesia
AIIMS Rishikesh
Rishikesh
Dehradun UTTARANCHAL 249201 India |
| Phone |
9340482058 |
| Fax |
|
| Email |
ajay.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Cardiac Anaesthesia
AIIMS Rishikesh
Rishikesh
Dehradun UTTARANCHAL 249201 India |
| Phone |
9340482058 |
| Fax |
|
| Email |
ajay.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
AIIMS Rishikesh
Rishikesh 249201
District Dehradun
Uttarakhand
uttarakhan |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| dr ayesha goyal |
Department of Cardiac Anesthesia |
Division of Cardiothoracic and Vascular Anesthesia
Dept of Anesthesia
All India Institute of Medical Sciences, Rishikesh, 249201 Dehradun UTTARANCHAL |
9741587051
ayesha.anaes@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Heart Visualisation on Transthoracic echocardiography |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Teaching |
Training in Transthoracic Echocardiography on Healthy Human Volunteers |
| Intervention |
Simulation |
Training in Transthoracic Echocardiography using Simulation |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Post graduate junior and senior residents with no or little exposure to echocardiography (Dept of Anaesthesia, Emergency medicine, Internal medicine and Pediatrics)
2. Consent to publish their test scores
|
|
| ExclusionCriteria |
| Details |
1. No consent
2. Second and third year residents in critical care training already having knowledge of basic echocardiography
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare cognitive and psycho-motor knowledge acquired by residents by two different training methods using image based test and grading of image acquisition two weeks after training period |
to compare cognitive and psycho-motor knowledge acquired by residents by two different training methods using image based test and grading of image acquisition two weeks after training period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare cognitive and psycho-motor knowledge acquired by residents by two different training methods using image based test and grading of image acquisition immediately after first training |
immediately |
| to compare scores of image based test and grading of image acquisition after first training and time gap of 2 weeks |
2 weeks |
| to compare basic knowledge of ECHO before and after lecture with help pre-test and post-test with objective MCQs |
immediately |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2022 |
| 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="0" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drayeshagoyal@gmail.com].
- For how long will this data be available start date provided 01-08-2022 and end date provided 31-07-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Medical training depends on real life experience with actual patients to hone the skills of health professionals at some point during the training. At the same time, there is a moral & ethical duty to provide suitable treatment and to ensure patient’s safety and well-being. These conflicting needs create a fundamental ethical tension in medical education, one that is widely recognized although little discussed. Medical training using simulation can prove to be a valuable tool in mitigating these ethical tensions and practical dilemmas. The concept of simulation as an educational tool in healthcare is not a new idea but its use has really blossomed over the last few years. This enthusiasm is partly driven by an attempt to increase patient safety and patient care and also because the technology is becoming more affordable and advanced besides number of advantages it presents over more traditional methods of teaching and learning.1Interest in simulation-based medical training has also increased due to challenges in medical education like increasingly limited availability of patients and instruction time, training in highly technical procedures, and the ethical issues raised by the patient safety movement.2 Anesthesiology is a hands-on specialty. As in other hands-on specialties such as surgery and emergency medicine, the only way to master a skill is to practice it again and again. Simulation provides a safe learning environment where anesthesiology residents and students can be taught, practice, and be evaluated on technical skills such as intubation and ventilation without ever putting a real patient at risk3. It is therefore not surprising that simulation has gained considerable interest and acceptance into anesthesiology education and curriculum. Anesthesiology is in fact the pioneer for the introduction of simulation into medical education4. Anesthesiology was instrumental in the development of a high fidelity human simulation used for medical education in other medical specialties as well. These developments represent a turning point at which simulation is no longer seen as a novelty whose existence needs to be justified or defended by a few staunch believers. Echocardiography is the commonest form of non-invasive cardiac imaging. However, being technically demanding, it is also operator dependent who are to be trained in a well defined pathway and require ongoing accreditation to achieve and maintain competency. However, to satisfy these requirements, significant time has to be dedicated to scanning patients, often in the time pressured clinical environment. Alternative, computer based simulated training methods are being considered to augment echocardiographic training and with considerable advancement in technology, development of interactive programs and simulators to train the clinicians has resulted in acquirement of skills to perform procedures. The more invasive specialties within the medical field including Anaesthesia also have exposure to simulation training, with simulators now available for teaching of bronchoscopy, transothoracic echocardiography (TTE) and transesophageal echocardiography (TEE). Training in TTE requires mastery over both technical and cognitive skills which has been achieved traditionally through didactics, observations, and independently performed examinations. We propose to undertake this prospective randomized superiority study to evaluate the impact of simulation in teaching basic echocardiography principles and skills of image acquisition and anatomy recognition to residents compared to traditional teaching methÂods like didactic lectures or hands-on exposure in TTE. |