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CTRI Number  CTRI/2020/04/024747 [Registered on: 21/04/2020] Trial Registered Prospectively
Last Modified On: 29/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   EFFECTIVENESS TO MANAGE COVID 19 PANDEMIC BY TEACHING VENTILATORY MANAGEMENT TO NON-ANAESTHESIOLOGY RESIDENTS  
Scientific Title of Study   EFFECTIVENESS OF SIMULATION BASED TEACHING OF VENTILATORY MANAGEMENT AMONG NON-ANAESTHESIOLOGY RESIDENTS TO MANAGE COVID 19 PANDEMIC.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  TATIKONDA CHANDRA MOULI 
Designation  ASSISTANT PROFESSOR 
Affiliation  GSL MEDICAL COLLEGE 
Address  DEPT OF ANAESTHESIOLOGY GSL MEDICAL COLLEGE RAJAHMUNDRY

East Godavari
ANDHRA PRADESH
533296
India 
Phone  9591654666  
Fax    
Email  chandradasavatar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  TATIKONDA CHANDRA MOULI 
Designation  ASSISTANT PROFESSOR 
Affiliation  GSL MEDICAL COLLEGE 
Address  DEPT OF ANAESTHESIOLOGY GSL MEDICAL COLLEGE RAJAHMUNDRY

East Godavari
ANDHRA PRADESH
533296
India 
Phone  9591654666  
Fax    
Email  chandradasavatar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  TATIKONDA CHANDRA MOULI 
Designation  ASSISTANT PROFESSOR 
Affiliation  GSL MEDICAL COLLEGE 
Address  DEPT OF ANAESTHESIOLOGY GSL MEDICAL COLLEGE RAJAHMUNDRY

East Godavari
ANDHRA PRADESH
533296
India 
Phone  9591654666  
Fax    
Email  chandradasavatar@gmail.com  
 
Source of Monetary or Material Support  
GSL MEDICAL COLLEGE RAJAHMUNDRY ANDHRA PRADESH  
 
Primary Sponsor  
Name  GSL MEDICAL COLLEGE 
Address  RAJAHMINDRY 
Type of Sponsor  Private medical college 
 
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 
TATIKONDA CHANDRA MOULI  SIMULATION LAB, GSL MEDICAL COLLEGE  RAJAHMUNDRY
East Godavari
ANDHRA PRADESH 
9591654666

chandradasavatar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE GSL MEDICAL COLLEGE AND GENERAL HOSPITAL   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NO ACTIVE INTERVENTIONS WILL BE DONE . OUR STUDY IS A TEACHING STUDY FOR RESIDENTS  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  To teach ventilatory management in COVID19 patients   classes will be conducted using HPS (human patient simualator ) and 3classes one on arterial blood gases ,one on basics of mechanical ventilation ,and finally mechanical ventilation in covid patients.A debriefing session will be carried out after every scenario, which will start with the trainee describing what happened during the scenario. This will be followed by analytical phase in which the trainee will be asked the successful aspects of the scenario and the factors that could have been improved. In the last phase of debriefing session, participants will be asked to reflect upon their training. A pre & post evaluation (Total 20 questions each carries 1 mark) will be conducted to assess the effectiveness of the in teaching module. The scores will be compared by wilcoxon sign rank test. Skill based assessment will be conducted by DOPS method. Feedback will be taken from the participants in a five point likert’s scale at the end of the teaching learning session.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  RESIDENTS OF DEPARTMENTS OF GENERAL SURGERY, ORTHOPEDICS, DERMATOLOGY, OPHTHALMOLOGY 
 
ExclusionCriteria 
Details  RESIDENTS OF ANAESTHESIOLOGY  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To prepare a module for non anesthesiology trainees to handle ventilators in management of COVID 19 patients.  1. To prepare a module for non anesthesiology trainees to handle ventilators in management of COVID 19 patients.
 
 
Secondary Outcome  
Outcome  TimePoints 
2. To evaluate the effectiveness of the testing module by conducting pre & post test and feedback.  2. To evaluate the effectiveness of the testing module by conducting pre & post test and feedback. 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2020 
Date of Study Completion (India) 01/05/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Mouli TC, Davuluri A, Vijaya S, Priyanka AD, Mishra SK. Effectiveness of simulation based teaching of ventilatory management among non-anaesthesiology residents to manage COVID 19 pandemic - A quasi experimental cross sectional pilot study. Indian J Anaesth 2020;64:S136-40. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Simulation has several potential applications in medical training and professional development in India.[1] It has long been integrated in anesthesiology training in modern day teaching curriculum. It has been used as a supplemental tool for training in high stake situations and life threatening events with the benefit of reducing patient safety concerns and permitting repetitive practice thus minimizing the margin of error. Rare conditions can be initiated to give trainees practice in patient management before encountering these challenges in clinical context [2].

One of the recent outbreaks that have gained global concern with rampant spread is COVID 19 pandemic. It has brought unprecedented challenges as the disease overwhelms health care systems and stresses the clinical workforce.

Majority of patients affected with COVID 19 require ICU admissions and few of them may also require mechanical ventilation [3], which has a very important role in the management of this pandemic.

Ventilator management requires highly trained professionals typically, intensive care physicians, anesthesiologists, respiratory therapists. But, because of risk involved in disease spread causing health care workers to become sick or worse, increase in mortality rate, the need of more number of experienced manpower to handle ventilator with knowledge on ventilators graphics becomes very much essential.

Due to the risk involved by patient exposure and to preserve protective equipment (PPEs), bed side teaching becomes more difficult

In order to supplement this shortage we have come up with an alternative for teaching ventilatory management in non anesthesiology residents.

Medical, nursing and other healthcare staff also have an opportunity to develop and refine their skills repeatedly, if necessary, using simulation technology without putting patients at risk.[4]

In medical education, there should be exposure to live patients so that medical students and doctors can acquire the necessary skills. There is also, on the other hand, an obligation to provide optimal treatment and to ensure patients’ safety and well-being. These two competing needs can sometimes pose a dilemma in medical education.[5]

We designed this study to meet the global requirement of knowledge on ventilatory management and due to paucity of literature in COVID patients.

Objectives:

1.     To prepare a module for non anesthesiology trainees to handle ventilators in management of COVID 19 patients.

2.     To evaluate the effectiveness of the testing module by conducting pre & post test and feedback.

 

 

METHODOLOGY:

A quasi experimental study will be conducted among 50 trainees who don’t have any prior exposure to handle ventilators. The study participants will be selected by non probability sampling and consent will be obtained from them after explaining the study. Institutional Ethical Committee clearance will be obtained from institutional ethical board GSL Medical College.

A teaching module will be prepared and validated which will consist Lectures on simulation guided ventilator graphics, audio-video sessions, demonstration as well as hands on training. A team of trained anesthetists will train the trainees on knowledge as well as skill based teaching with the help of the teaching module and HPS simulator. Total 2 sessions will be conducted with 25 trainees in each.

The human patient (HPS) simulator is a human sized high fidelity mannequin with features such as palpable pulses, chest wall expansion, audible breath sounds, and facility for intubation; scenarios can be created and respond to anaesthetics and COVID pneumonia like picture can be modeled.

A debriefing session will be carried out after every scenario, which will start with the trainee describing what happened during the scenario. This will be followed by analytical phase in which the trainee will be asked the successful aspects of the scenario and the factors that could have been improved. In the last phase of debriefing session, participants will be asked to reflect upon their training.

A pre & post evaluation (Total 20 questions each carries 1 mark) will be conducted to assess the effectiveness of the in teaching module. The scores will be compared by wilcoxon sign rank test.

Skill based assessment will be conducted by OSCE method.

Feedback will be taken from the participants in a five point likert’s scale at the end of the teaching learning session.

 
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