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CTRI Number  CTRI/2024/02/062971 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Improving Anesthesia Resident Proficiency: Assessing the Effects of a Training Initiative on Handling Challenging Airway Scenarios in Resource-Limited Environments 
Scientific Title of Study   Assessing the impact of comprehensive training curriculum on management of unanticipated difficult airway among anaesthesia resident doctors in a resource constraint setting: A before and after implementation study using Kirkpatricks model 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Naveen Paliwal 
Designation  Associate Professor 
Affiliation  Dr. S. N. Medical College Jodhpur 
Address  Department of anaesthesiology, simulation laboratory first floor Mahatma Gandhi hospital. Jodhpur

Jodhpur
RAJASTHAN
342001
India 
Phone  9950230213  
Fax    
Email  drnaveenpaliwal@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naveen Paliwal 
Designation  Associate Professor 
Affiliation  Dr. S. N. Medical College Jodhpur 
Address  Department of anaesthesiology, simulation laboratory first floor Mahatma Gandhi hospital. Jodhpur


RAJASTHAN
342001
India 
Phone  9950230213  
Fax    
Email  drnaveenpaliwal@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Naveen Paliwal 
Designation  Associate Professor 
Affiliation  Dr. S. N. Medical College Jodhpur 
Address  DDepartment of anaesthesiology, simulation laboratory first floor Mahatma Gandhi hospital. Jodhpur


RAJASTHAN
342001
India 
Phone  9950230213  
Fax    
Email  drnaveenpaliwal@yahoo.com  
 
Source of Monetary or Material Support  
Dr S N Medical College Jodhpur Rajasthan 
 
Primary Sponsor  
Name  Dr S N Medical College 
Address  Jodhpur Rajasthan 
Type of Sponsor  Government 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 
Dr Naveen Paliwal  Mahatma Gandhi Hospital Jodhpur  Department of anaesthesiology, simulation laboratory first floor Mahatma Gandhi hospital. Jodhpur
Jodhpur
RAJASTHAN 
09950230213

drnaveenpaliwal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr.Sampurnanand Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  comprehensive training curriculum on management of unanticipated difficult airway   Phase 1- Subsequent to the simulation, participants will be called two days later for didactic lectures on airway management. Practical activities, such as demonstrating and practicing surface anatomy, positioning and laryngeal handshake on manikins and volunteers, will reinforce learning. Concepts like the DAS guidelines and local equipment variations will be discussed. After three days, participants will be called to practice cricothyroidotomy on a task trainer. Faculty will demonstrate the steps, followed by participants repeated practice until they can perform all steps correctly within a set timeframe (within120 seconds). The WhatsApp group will serve as a platform for sharing guidelines, videos, and literature. Phase 2- After 2 weeks, participants will be called for the simulation session. Individualized scheduling will be arranged, and the same scenario will be run with variations in case descriptions. Objective and subjective assessments on same parameters will be conducted, followed by a structured debriefing to identify improvements and latent threats. Following this, participants will be provided a proforma and encouraged to report any case of difficulties encountered during airway management in real world and their change in practice till next meeting. (appendix 6) Either of faculty will observe participants behaviour in dealing with difficult airway at OR/ICU complex of the institute. (appendix 7) These proforma will be handed over to either of the faculty. Phase 3- Participants will undergo the same simulation scenario after 6 months, allowing assessment of their retention of skills.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Resident doctors of anaesthesia department with at least 12 months of exposure will be included.  
 
ExclusionCriteria 
Details  exclusion criteria will be refusal to participate in the study. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Following this, the training curriculum effectiveness will be assessed by Kirkpatrick model.
KP 1(reaction)- A Google form consisting of set of questionnaire will be given to all participants to gather feedback. (appendix 8)
KP2 (learning)- A semi-structured interview of participants will be recorded and then themes will be prepared out of those interview transcripts to see the learning of participants from the curriculum. Simultaneously improvement in individual skills will be assessed by comparing data at 2 weeks to that at baseline. Retention of skills will be evaluated by comparing subjective and objective rating at 6 months from 2 weeks.
KP3 (behaviour): All the proforma filled up by the participants and observers between phase 2 and 3 will be evaluated by both the faculties to see the change in behaviour and practice of participant to handle airway emergencies.
 
6-7 months 
 
Secondary Outcome  
Outcome  TimePoints 
KP3 (behaviour): All the proforma filled up by the participants and observers between phase 2 and 3 will be evaluated by both the faculties to see the change in behaviour and practice of participant to handle airway emergencies.   6-7 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   11/03/2024 
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="6"
Days="21" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

There is significant gap in our approach to training and preparedness especially dealing in crisis situation of rare events such as unanticipated difficult airway. The question is,  how do we bridge that gap and ensure our residents are equipped with the knowledge, skills and confidence to tackle even the most challenging situations? High fidelity simulation scenario based teaching complement traditional way of teaching where students can acquire technical as well as non-technical skills to deal with unanticipated difficult airway effectively.

Research question:

Does comprehensive training curriculum on management of unanticipated difficult airway impact acquisition and retention of skills (technical and non-technical) among anesthesia residents?

Hypothesis:

H1: Implementation of comprehensive training curriculum will positively affect the attitude and confidence of anaesthesia trainee to handle airway emergencies in real world

H2: Implementation of comprehensive training curriculum on management of unanticipated difficult airway will decrease the total procedural time (time from declaring CICO situation to confirmation of ventilation)

H3: Implementation of comprehensive training curriculum on unanticipated difficult airway management will have no effect on retention of skills.

P: Resident Doctors of our Institute who have completed 12 months of training (2nd year and 3rd year JRs)

I: Comprehensive training curriculum on management of unanticipated difficult airway

C: Before and after intervention

O: Impact on skills and behavior to deal with unanticipated difficult airway in real-life (Kirkpatrick’s level 1 to 3)

Outcome assessment:

Following this, the training curriculum effectiveness will be assessed by Kirkpatrick model.

KP 1(reaction)- A Google form consisting of set of questionnaire will be given to all participants to gather feedback. (appendix 8)

KP2 (learning)-  A semi-structured interview of participants will be recorded and then themes will be prepared out of those interview transcripts to see the learning of participants from the curriculum. Simultaneously improvement in individual skills will be assessed by comparing data at 2 weeks to that at baseline. Retention of skills will be evaluated by comparing subjective and objective rating at 6 months from 2 weeks.

KP3 (behaviour): All the proforma filled up by the participants and observers between phase 2 and 3 will be evaluated by both the faculties to see the change in behaviour and practice of participant to handle airway emergencies. 

Phase (time frame)

Description

Preparation (15 days)

Course material, scenario script, simulation area, participants, faculty training, embedded participants training, rehearsal

Baseline (after 1 week of preparation)

Simulation scenario- subjective and objective assessment

Phase 1 (After 3 days)

Didactic lectures, vortex cognitive aid, video demonstration, demonstration on volunteers and manikins, practice on task trainer

Phase 2 (After 2 weeks)

Simulation scenario- subjective and objective assessment, structured debriefing

Self-evaluation and observation at real patient care

Phase 3 (After 6 months)

Simulation scenario- subjective and objective assessment, structured debriefing.

Evaluation

Using Kirkpatrick Model level 1, 2 and 3

Data collection and analysis


 
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