FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/034684 [Registered on: 08/07/2021] Trial Registered Prospectively
Last Modified On: 06/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessing competency of Anaesthesia Residents in Trans Thoracic Echocardiography with or without using a simulator 
Scientific Title of Study   Competency of novice Anaesthesia residents in Trans Thoracic Echocardiography with or without structured problem-based hands on course using simulator: A Randomized 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 Manpreet Kaur  
Designation  Assistant Professor  
Affiliation  All India Institute Of Medical Sciences, New Delhi.  
Address  Department of Anaesthesiology, pain medicine and critical care, Fifth floor, Academic block,All India Institute Of Medical Sciences ,Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9868595487  
Fax    
Email  manpreetkaurrajpal@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manpreet Kaur  
Designation  Assistant Professor  
Affiliation  All India Institute Of Medical Sciences, New Delhi.  
Address  Department of Anaesthesiology, pain medicine and critical care, Fifth floor, Academic block,All India Institute Of Medical Sciences ,Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9868595487  
Fax    
Email  manpreetkaurrajpal@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharat Yalla 
Designation  Junior Resident  
Affiliation  All India Institute Of Medical Sciences,New Delhi  
Address  Department of Anaesthesiology, pain medicine and critical care , Fifth floor, Academic Block, All India Institute Of Medical Sciences, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  8328472590  
Fax    
Email  bharat.yalla1@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Pain Medicine and Critical Care, All India Institute Of Medical Sciences,New Delhi. 
 
Primary Sponsor  
Name  Dr Manpreet Kaur  
Address  Department of Anaesthesiology Pain Medicine and Critical Care,All India Institute Of Medical Sciences, New Delhi  
Type of Sponsor  Other [Self] 
 
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 Manpreet Kaur   AIIMS, Ansari Nagar,New Delhi-110029  Department of Anaesthesiology Pain Medicine and Critical Care, All India Institute Of Medical Sciences,New Delhi.
South
DELHI 		 9868595487

manpreetkaurrajpal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee,AIIMS New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Novices  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Training Trans Thoracic Echocardiography using a simulator   Intervention group will receive a hands-on reinforcement training on TTE simulator about normal views and 5 pathologic clinical conditions over 2weeks 
Comparator Agent  Video based training of Trans Thoracic Echocardiography   Control Group will receive video-based training about normal views and 5 pathologic clinical conditions over 2weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Anaesthesia junior residents with > 6months of training in Department of Anaesthesia  
 
ExclusionCriteria 
Details  1)Residents who have previously participated in TTE training. 2)Residents who have already performed any TTE in their past.
3)Participant refusal.  
 
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 
To assess whether a structured problem based TTE simulator course improves the competency score (CS) of novice anaesthesia residents.  2 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1 Time taken for image plane acquisition of
each standard TTE view.
2)Number of attempts made to diagnose and to achieve image plane.
3)Time taken to diagnose the pathological clinical scenario provided during assessment.
4)Self-assessment of students level of confidence after the course.
5)Retention of skills after 6 months. 		 6 months follow up  
 
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   N/A 
Date of First Enrollment (India)   13/07/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  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 [bharat.yalla1@gmail.com].

  6. For how long will this data be available start date provided 21-08-2023 and end date provided 21-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Trans Thoracic Echo (TTE) is a noninvasive procedure that can be performed bedside with immediate results. Basic training in TTE can facilitate in early learning and aid in qualitative and semiqualitative analysis of patients. Competency in critical care ultrasonography has become part of the intensivists curriculum. However, it has not been incorporated into the postgraduate curriculum. Simulation-based training is an increasingly popular approach as it facilitates the learners to practice their clinical and decision-making skills by mimicking the real-life situational experiences. Spectrum of simulation ranges from low fidelity to high-fidelity simulation. Difficulty in spatial orientation by beginners with reference of 3-dimensional (3D) heart geometry can be overcome by using Simulator. Simulators improve learning for bedside hemodynamic assessment , diagnosis and management of multiple scenarios.Hence, TTE simulator training in image acquisition can enable training of novice learners on real patients. A structured program is however needed to impart a cohesive training to residents. Such a program will not only provide comprehensive training regarding the common views that the residents need to master but also help them understand and diagnose common clinical pathologies they may encounter in practice. The present study is designed to assess the competency of Anaesthesia residents in Trans Thoracic Echocardiography with or without structured problem-based hands on course using TTE simulator. This study will help in realizing the utility of such a program and its introduction into the anaesthesia curriculum program. 


1. Expert Round Table on Ultrasound in ICU. International expert statement on training standards for critical care ultrasonography. Intensive Care Med. 201 I Jul;37(7):1077-83.
 2. Gillebert TC, Brooks N, Fontes-Carvalho R, Fras z, Gueret P, Lopez-Sendon J, et al. ESC core curriculum for the general cardiologist (2013). Eur Heart J. 2013 Aug;34(30):2381-411. 
3. Quinones MA, Douglas PS, Foster E, Gorcsan J, Lewis JF, Pearlman AS, et al. ACC/AHA clinical competence statement on echocardiography: a report of the American College of Cardiology/American Heart Association/American College of Physicians-American Society of Internal Medicine Task Force on clinical competence. J Am Soc Echocardiogr Off Pub! Am Soc Echocardiogr. 2003 Apr;16(4):379-402.
 4. Ryan T, Armstrong WF, Khandheria BK, American Society ofEchocardiography. Task force 4: training in echocardiography endorsed by the American Society ofEchocardiography. J Am Coll Cardiol. 2008 Jan 22;51(3):361-7.
 5. Fox KF, Popescu BA, Janiszewski S, Nihoyannopoulos P, Fraser AG, Pinto FJ, et al. Report on the European Association ofEchocardiography accreditations in echocardiography: December 2003-September 2006. Eur J Echocardiogr J Work Group Echocardiogr Eur Soc Cardiol. 2007 Jan;S(l):74-9. 
6. 2019 ACC/ AHA/ ASE Advanced Training Statement on Echocardiography (Revision of the 2003 ACC/AHA Clinical C~mpetence Statement on Echocardiography): A Report of the ACC Competency Management Committee I Circulation: Cardiovascular Imaging [Internet]. [cited 2021 Jan 9]. Available from: https://www.ahajoumals.org/doi/10.1161/HCl.0000000000000026 
7. Guldbrand Nielsen D, Jensen SL, O’Neill L. Clinical assessment oftransthoracic echocardiography skills: a generalizability study. BMC Med Educ [Internet]. 2015 Feb 1 [cited 2021 Jan 9]; 15. Available from: https:/ /www .ncbi.nlm.nih.gov/pmc/articles/PMC4334848/ 
8. (10) (PDF) Competence oflntensivists in Focused Transthoracic Echocardiography in Intensive Care Unit: A Prospective Observational Study [Internet]. [cited 2021 Jan 9]. Available from: https://www.researchgate.net/publication/325 l 99 I 44 _Competence_ of_ Intensivists _in_ Focused_ Transtho racic _Echocardiography _in_ Intensive_ Care_ Unit_A _Prospective_ Observational_ Study
 9. Alexander JH, Peterson ED, Chen AY, Harding TM, Adams DB, Kisslo JA. Feasibility of poiot-of-care echocardiography by internal medicine house staff. Am Heart J. 2004 Mar;l47(3):476-81.
 IO. Beraud A-S, Rizk NW, Pearl RG, Liang DH, Patterson AJ. Focused transthoracic echocardiography during critical care medicine training: curriculum implementation and evaluation of proficiency*. Crit Care Med. 2013 Aug;4 l (8):e 179-181. 
11. Vignon P, Pegot B, Dalmay F, Jean-Michel V, Bocher S, L’her E, et al. Acceleration of the learning curve for mastering basic critical care echocardiography using computerized simulation. Intensive Care Med. 2018 Jul;44(7):1097-105. 
 
Close