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CTRI Number  CTRI/2024/09/073482 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 30/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Experiences and challenges faced by health care workers when doing cardiopulmonary resuscitation (CPR) in a moving ambulance in a simulated setting 
Scientific Title of Study   Musculoskeletal discomfort, CPR quality and provider experiences during cardiopulmonary resuscitation in transit ambulance setting 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Caroline Ashritha Maben  
Designation  Postgraduate Student 
Affiliation  Manipal College of Health Professions 
Address  LH 9 6th floor Department of Emergency Medical Technology Manipal College of Health Professions MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9535730279  
Fax    
Email  caroline.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prithvishree Ravindra 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Emergency Medicine Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9035296971  
Fax    
Email  prithvishree.r@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Prithvishree Ravindra 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Emergency Medicine Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9035296971  
Fax    
Email  prithvishree.r@manipal.edu  
 
Source of Monetary or Material Support  
Department of Emergency Medicine Kasturba Medical College and Hospital Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104 
 
Primary Sponsor  
Name  Department of Emergency Medicine 
Address  Department of Emergency Medicine, Kasturba Medical College, Manipal, Udupi Karnataka PIN-576104 
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 
Caroline Ashritha Maben  Kasturba Hospital Manipal  Department of Emergency Medicine Kasturba Medical College and Hospitals Manipal Academy of Higher Education Manipal - 576104
Udupi
KARNATAKA 
9535730279

caroline.mchpmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Hospitals Institutional ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health care workers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Participants must have demonstrated competency in BLS through curriculum 
 
ExclusionCriteria 
Details  1. Residual pain from musculoskeletal injuries
2. Recent musculoskeletal injuries 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain numeric rating scale  After 12 minutes of CPR 
 
Secondary Outcome  
Outcome  TimePoints 
Experience of doing CPR in ambulance through qualitative interview guide  After 12 minutes of CPR 
 
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)   10/09/2024 
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="8"
Days="0" 
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  
The research aims to study the Musculoskeletal discomfort, CPR quality and provider experiences during CPR in transit ambulance setting. Our primary objectives is to examine the change in Pain numeric rating scale subsequent to 12 minutes of cardiopulmonary resuscitation within a simulated scenario involving a manikin situated in a moving Ambulance and to explore the experiences of delivering Cardiopulmonary Resuscitation in a moving Ambulance. Secondary objective is to study the quality of CPR delivered in a moving ambulance using CPR feedback device and compare the differences in the body posture analysis during CPR between stationary out of ambulance setting and moving ambulance setting. The study will be carried out for 8 months and the sample size is 30 which involves Healthcare workers who are more than 18 years of age, both the sexes and must have demonstrated competency in BLS through curriculum. After obtaining approval from Institutional Ethics Committee and CTRI registration, collection of data shall be initiated. Overview of the study objectives, procedures will be explained to the participants before obtaining the informed consent. Participants will perform CPR as per the CPR protocols in a moving ambulance during which their safety will be monitored. Followed by that individual interviews will be conducted with participants using the interview guide to explore their experiences, perceptions, and challenges encountered during the CPR simulation. 
 
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