| 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
|
|
|
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
|
|
|
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. |