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CTRI Number  CTRI/2025/02/080172 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Other 
Public Title of Study   A quality improvement study focused on enhancing care of patients after heart stoppage, through the introduction of a standardized care protocol 
Scientific Title of Study   Implementation of post-resuscitation care bundle and its impact on Cardio-Pulmonary Resuscitation outcomes: A quality improvement study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahima Kote J 
Designation  Doctoral scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8867122908  
Fax    
Email  mahima.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sagar M S 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal  
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9764391100  
Fax    
Email  sagar.ms@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sagar M S 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal  
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9764391100  
Fax    
Email  sagar.ms@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India- 576104 
 
Primary Sponsor  
Name  Mahima Kote J 
Address  Department of Critical Care Medicine, Kasturba Medical College, MAHE, Manipal 
Type of Sponsor  Other [Self sponsored] 
 
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 
Mahima Kote J  Kasturba Hospital Intensive Care Units   Intensive Care Units 1 and 2, Department of Critical Care Medicine, First floor, New Trauma Block, Kasturba Hospital, Manipal, Udupi
Udupi
KARNATAKA 		 8867122908

mahima.kmcmpl2023@learner.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 
Patients  (1) ICD-10 Condition: I469||Cardiac arrest, cause unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Introduction of post cardiac arrest care bundles.  A post cardiac care bundle will be used for training the healthcare providers who manage cardiac arrest patients in ICU. This will be an educational bundle which will be developed after initial observation period. 
Comparator Agent  Observation of post cardiac arrest care  In the initial phase of the study, post cardiac arrest care provided to patients will be observed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Cardiac arrest patients above the age of 18 who have achieved Return Of Circulation and admitted to ICU, will be included in the study.  
 
ExclusionCriteria 
Details  Patients with a history of trauma and head injury, cerebrovascular accidents and existing terminal illness will be excluded from the study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the change in the adherence to guidelines after the introduction of post resuscitation care bundle  One hour and four hours post cardiac arrest 
 
Secondary Outcome  
Outcome  TimePoints 
To study the incidence of neurologically intact survivors after the introduction of post cardiac arrest care bundles.   At one month and six months 
 
Target Sample Size   Total Sample Size="162"
Sample Size from India="162" 
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)   20/02/2025 
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="3"
Months="0"
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 is a quality improvement pre-post quasi experimental study which includes observation of the care provided to the post cardiac arrest patients in the Intensive Care Units. In the initial observational phase, we plan to check the adherence of the  care provided to the patients, per the standard guidelines . Subsequently, we will develop a care bundle, based on the  analysis of  observational phase and existing post cardiac arrest care guidelines. The care bundle thus developed, will be validated and implemented in the ICU and adherence to the care will be observed, in the post-implementation period. The study will be conducted for over  three years with initial 10 months period for observation of adherence to standard post cardiac arrest care guidelines and four months for development and validation of care bundles. Implementation of care bundle will be done in the subsequent 10 months. We plan to see if the introduction of post cardiac arrest care bundles helps to improve survival with better neurological functions, for which, we will check short term and long term neurological functions at one month and six months follow up. 

 
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