| 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 |
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Scientific Title of Study
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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 |
|
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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 |
|
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Source of Monetary or Material Support
|
| Dr S N Medical College Jodhpur Rajasthan |
|
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Primary Sponsor
|
| Name |
Dr S N Medical College |
| Address |
Jodhpur Rajasthan |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
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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 |
|
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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. |
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
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Primary Outcome
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| 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 |
|
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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" |
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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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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