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CTRI Number  CTRI/2022/09/045269 [Registered on: 06/09/2022] Trial Registered Prospectively
Last Modified On: 05/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of activity level in post - surgery patients in ICU using Chlesea critical care Physical assessment tool .  
Scientific Title of Study   Evaluation of physical function in post- surgery patients in ICU using Chelsea critical care physical assessment tool. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kruti Rao 
Designation  PG-Student 
Affiliation  Colllege of Physiotherapy,Sumandeep Vidhyapeeth ,an Institution deemed to be University 
Address  PG Classroom, on ground floor, College of Physiotherapy, Sumandeep Vidyapeeth, an Institution deemed to be University, at and post Pipariya, Taluka - Waghodia, Vadodara Gujarat 391760 India

Vadodara
GUJARAT
391760
India 
Phone  8320167409  
Fax    
Email  kruti.k.rao98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nirali Pandya 
Designation  Assistant Professor and Guide 
Affiliation  Colllege of Physiotherapy,Sumandeep Vidhyapeeth ,an Institution deemed to be University 
Address  Staffroom,on ground floor, College of Physiotherapy, Sumandeep Vidyapeeth, an Institution deemed to be University, at and post Pipariya, Taluka - Waghodia, Vadodara Gujarat 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9377845977  
Fax    
Email  niralipandya.cop@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nirali Pandya 
Designation  Assistant Professor and Guide 
Affiliation  Colllege of Physiotherapy,Sumandeep Vidhyapeeth ,an Institution deemed to be University 
Address  Staffroom,on ground floor, College of Physiotherapy, Sumandeep Vidyapeeth, an Institution deemed to be University, at and post Pipariya, Taluka - Waghodia, Vadodara Gujarat 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9377845977  
Fax    
Email  niralipandya.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
This is a Self-Funded Study. The Infrastructure is provided by College of Physiotherapy, Sumandeep Vidyapeeth an Institution Deemed to be University, at and post Pipariya, Taluka - Waghodia, Vadodara, Gujarat, India -39176 
 
Primary Sponsor  
Name  Kruti Rao 
Address  College of Physiotherapy, Sumandeep Vidyapeeth, an Institution deemed to be University, at and post Pipariya, Taluka - Waghodia, Vadodara Gujarat 391760 India 
Type of Sponsor  Other [Self] 
 
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 
Kruti Rao  Mastama heart centre, 2nd floor old building, and SICU 2nd floor New building.   Dhiraj General Hospital, sumandeep Vidyapeeth, at and post Pipariya, Taluka - waghodiya, Vadodara, Gujarat 391760
Vadodara
GUJARAT 
8320167409

kruti.k.rao98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I70||Atherosclerosis, (2) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (3) ICD-10 Condition: K35-K38||Diseases of appendix, (4) ICD-10 Condition: K40-K46||Hernia, (5) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (6) ICD-10 Condition: I20-I25||Ischemic heart diseases, (7) ICD-10 Condition: I05-I09||Chronic rheumatic heart diseases, (8) ICD-10 Condition: K65-K68||Diseases of peritoneum and retroperitoneum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Post operative Cardiac and Abdominal surgery patients
ICU length of stay of over 72 hours
Anticipated to survive their hospital stay
 
 
ExclusionCriteria 
Details  Hemo-dynamically unstable patients
Comatose patients
Patients with neurological conditions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Chelsea critical care physical assessment tool  3 times in 1 year research study 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   12/09/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

                            This is the cross-sectional observational study. After CTRI registration the post- operative cardiac and abdominal surgery patients of Dhiraj General Hospital from Sumandeep Vidyapeeth will be approached. The study includes both male and female of age over 18 years or above who will be at ICU length of stay over 72 hours and are anticipated to survive their hospital stay and excludes Hemo-dynamically unstable patients, Comatose patients, Patients with neurological conditions. Patients those who are fulfilling the inclusion criteria will be requested for a written informed consent form and participation information sheet will be given. Then the subject will be screened as per the assessment format. Post - surgery will lead  to pathological changes such as respiratory muscle dysfunction due to altered muscle integrity, length-tension relationship, and thoracoabdominal mechanism, leading to postoperative pulmonary complications (PPCs). The Chelsea critical care physical assessment tool will be is used to measure physical function in   post - surgery patients in ICU. Conventional physical therapy treatment will be given from the first day of admission. The CPAx scale will be taken on POD-1, POD-3, POD-6 and at the day of discharge from the ICU, to assess the physical function status of the patient. So, this study aims to evaluate the physical function in post-surgical patients in ICU using Chelsea critical care physical assessment tool.

 
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