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
|
|
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
|
|
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
|
|
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. |