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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drayeshagoyal@gmail.com].

  6. 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.

  7. 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 meth­ods like didactic lectures or hands-on exposure in TTE.

 
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