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CTRI Number  CTRI/2025/10/096311 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal study 
Study Design  Single Arm Study 
Public Title of Study   Improving emergency airway care through simulation training and teamwork assessment. 
Scientific Title of Study   Effectiveness of in-situ simulation and human factors analysis using quality improvement cycles to mitigate latent safety threats in emergency airway management 
Trial Acronym  SAFE AIRWAY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SUBASHINI G 
Designation  PG student 
Affiliation  Jawaharlal institute of postgraduate medical education and research  
Address  Emergency medicine department,ED division,EMSD building,Dhanvantri nagar,JIPMER pondicherry, PONDICHERRY 605006 India
Dr MANU AYYAN Emergency medicine division,first floor EMSD building,Dhanvantri nagar,JIPMER pondicherry, PONDICHERRY 605006 India
Pondicherry
PONDICHERRY
605006
India 
Phone  6369768233  
Fax    
Email  subashiniganesan91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manu Ayyan 
Designation  Associate professor 
Affiliation  Jawaharlal institute of postgraduate medical education and research  
Address  No 7,Emergency medicine department,ED division,first floor EMSD building,Dhanvantri nagar,JIPMER pondicherry, PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  9846556133  
Fax    
Email  manuayyan.s@jipmer.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr SUBASHINI G 
Designation  PG student 
Affiliation  Jawaharlal institute of postgraduate medical education and research  
Address  Emergency medicine department,ED division,EMSD building,Dhanvantri nagar,JIPMER pondicherry, PONDICHERRY 605006 India
Dr MANU AYYAN Emergency medicine division,first floor EMSD building,Dhanvantri nagar,JIPMER pondicherry, PONDICHERRY 605006 India

PONDICHERRY
605006
India 
Phone  6369768233  
Fax    
Email  subashiniganesan91@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Instuitute of Postgraduate Medical Education and Research,Dhanwantri Nagar,Puducherry,605006 India 
 
Primary Sponsor  
Name  Jawaharalal institute of postgraduate medical education and research 
Address  Jawaharlal institute of postgraduate medical education and research, Dhanvantri nagar,Puducherry 605006 India. 
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 Subashini   Jawaharlal institute of postgraduate medical education and research  No 3, Research Division,Emergency Medicine Department,First Floor EMSD building,Dhanvantri nagar,JIPMER pondicherry, PONDICHERRY 605006 India
Pondicherry
PONDICHERRY 		 6369768233

subashiniganesan91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee interventional studies jipmer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy participants undergoing simulation training 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  All Emergency department clinical staff including emergency physicians,residents,nurses,Emergency medicine technicians rostered for duty during scheduled simulation windows. 
 
ExclusionCriteria 
Details  Staff not typically involved in airway management.visiting or temporary staff unfamiliar with Emergency Medicine protocol. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure change in quantified profile of latent safety threats over the study period.

To measure the trend in LST frequency per simulation.

To measure the trend in mean LST hazard score per simulation.

To measure the Change in frequency of critical LSTs.
 		 Baseline.

After each PDSA cycle.

At the end of study period.
 
 
Secondary Outcome  
Outcome  TimePoints 
Time to scuccessful intubation.

Categorization of Latent safety threats.

Feasibility and Team acceptability. 		 Baseline.

After each PDSA cycles.

At the end of the study period. 
 
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)   01/11/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study is designed to evaluate the effectiveness of insitu simulation combined with the human factors analysis and Quality improvement cyclesin identifying and mitigating latent safety threats in emergency airway management.Emergency airway procedures are high risk and time sensitive requiring coordinated team work.Through structured insitu simulation exercises conducted in the Emergency Department the study aims to identify system level gaps and human factor issues that can compromise patient safety.

Following each simulation a structured debriefing and human factor analysis will be carried out to catogorize LSTs.Based on the findings, targeted interventions will be implemented using Plan Do Study Act cycles.The effectiveness of these interventions will be assessed by monitoring changes in the frequency,severity,and nature of LSTs over the time.

Participants will include healthcare workers involved in aiway management including emergency physicians, residents,nurses,emergency medical technicians,and interns.The study is intented to contribute to improved patient outcomes and enhanced team based care in high stakes emergency situations.
 
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