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CTRI Number  CTRI/2025/01/079585 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 10/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Emergency department design evaluation to increase its capacity 
Scientific Title of Study   Assessment of spatial design for disaster preparedness in tertiary care hospitals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shriharsh Ashok Dixit 
Designation  Assistant Professor- Selection Grade 
Affiliation  Manipal School of Architecture & Planning 
Address  Cabin A4, Architecture Department, Manipal School of Architecture & planning, 80 Badagabettu, Manipal, Udupi District, Karnataka, India
Cabin A4, Architecture Department, Manipal School of Architecture & planning, 80 Badagabettu, Manipal, Udupi District, Karnataka, India
Udupi
KARNATAKA
576104
India 
Phone  9481341241  
Fax    
Email  shriharsh.dixit@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Nandineni Rama Devi 
Designation  Professor 
Affiliation  Manipal School of Architecture & Planning 
Address  Architecture Department, Manipal School of Architecture & planning, 80 Badagabettu, Manipal, Udupi District, Karnataka, India
Architecture Department, Manipal School of Architecture & planning, 80 Badagabettu, Manipal, Udupi District, Karnataka, India
Udupi
KARNATAKA
576104
India 
Phone  9535996529  
Fax    
Email  nandineni.rd@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Shriharsh Ashok Dixit 
Designation  Assistant Professor- Selection Grade 
Affiliation  Manipal School of Architecture & Planning 
Address  Cabin A4, Architecture Department, Manipal School of Architecture & planning, 80 Badagabettu, Manipal, Udupi District, Karnataka, India
Cabin A4, Architecture Department, Manipal School of Architecture & planning, 80 Badagabettu, Manipal, Udupi District, Karnataka, India
Udupi
KARNATAKA
576104
India 
Phone  09481341241  
Fax    
Email  shriharsh.dixit@manipal.edu  
 
Source of Monetary or Material Support  
Shriharsh Ashok Dixit (Individual) Cabin A-4, Architecture Department, Manipal School of Architecture & planning, 80 Badagabettu, Manipal, Udupi District, Karnataka, India 
 
Primary Sponsor  
Name  Shriharsh Ashok Dixit Individual 
Address  Cabin A-4, Architecture Department, Manipal School of Architecture & planning, 80 Badagabettu, Manipal, Udupi District, Karnataka, India 
Type of Sponsor  Other [Principal Investigator] 
 
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 Somu G  Kasturba Hospital  Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India 576104
Udupi
KARNATAKA 		 9448463186

somu.g@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  VOLUNTEERS WHO HAVE EXPERIENCED DISASTER SITUATION IN HOSPITAL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Hospital Staff: healthcare professionals from various departments, such as doctors, nurses, paramedics, and administrators, who have direct involvement in disaster preparedness and response.
2. Relevant Experience: participants who have experienced or participated in disaster management activities, disaster drills, or actual disaster response.
3. Different Roles: individuals from different roles within the hospital, such as emergency department staff, intensive care unit staff, administration, and logistics.
4. Diverse Perspectives: participants from different levels of experience, varying lengths of service, and different demographic backgrounds to represent a broad range of perspectives.
 
 
ExclusionCriteria 
Details  Non-Hospital Staff: individuals who do not work directly in the hospital and are not involved in disaster preparedness and response activities.
2. Lack of Relevant Experience: participants who have no prior experience or involvement in disaster management or response.
3. Unrelated Roles: individuals whose roles and responsibilities are not directly related to disaster preparedness and response within the hospital.
4. Overrepresentation: excessive number of participants from a single department or role creating unbalanced representation across various hospital functions.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To document the experience of spatial organization and their characteristics affecting the movement and circulation in Hospitals during disasters.  4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze the spatial characteristics affecting disaster preparedness in hospitals.  4 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

To study the disaster preparedness of hospitals, hospitals in India are to be considered. These hospitals shall be selected by the recommendation of DAC members. The study is divided in 2 parts. The first part consists of observation study where various departments of the hospital involved in disaster preparedness shall be focused. The second part of the study shall involve stakeholders of the hospital for Focused Group Discussions (FGDs). The outcome of the study shall be again validated using Delphi method from the stakeholders.

DAC Approved hospitals shall be contacted for the permission of the study. After the receipt of permission, consent forms (MS Forms) shall be shared with the members mentioned in inclusion criteria giving them complete understanding of the purpose of the study.

Upon receiving consent, interested participants shall be categorized based on their inclusion criteria and shall be given date for the Focus Group Discussions (FGD). A moderator shall be identified and selected for the discussion. Required materials shall be made available for the FGDs. The discussion shall be semi structured to allow participants to provide in depth details. The members also shall be contacted for Delphi method for validation purposes.

 
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