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CTRI Number  CTRI/2022/09/045883 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 24/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to examine the muscle weakness in intensive care unit patients 
Scientific Title of Study   Early diagnosis of ICU acquired weakness in mechanically ventilated patients in intensive care unit 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zeal Chheda 
Designation  Physiotherapy postgraduate student 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9819817448  
Fax    
Email  zeal.chheda@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr G Arun Maiya 
Designation  Professor and Dean 
Affiliation  Manipal College of Health Professions 
Address  Manipal College of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Anup Bhat 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9916820026  
Fax    
Email  anup.bhat@manipal.edu  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Manipal College of Health Professions 
Address  Academic tower 2 Near MMMC, Manipal Academy of Higher Education Manipal Udupi Karntataka 
Type of Sponsor  Research institution 
 
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 
Zeal  Department of Critical Care Medicine  Kasturba Medical College and Hospital Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA 		 9819817448

zeal.chheda@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J962||Acute and chronic respiratory failure, (2) ICD-10 Condition: Z992||Dependence on renal dialysis, (3) ICD-10 Condition: Z991||Dependence on respirator, (4) ICD-10 Condition: G728||Other specified myopathies, (5) ICD-10 Condition: G628||Other specified polyneuropathies, (6) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, (7) ICD-10 Condition: R652||Severe sepsis, (8) ICD-10 Condition: T794||Traumatic shock,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients on mechanical ventilation in ICU for more than 48 hours
APACHE II score more than 12 
 
ExclusionCriteria 
Details  Diagnosed with pre existing neuromuscular disease
Pregnancy
Pre existing systemic vascular involvement such as systemic lupus erythematous
Patients on inotropes. Dosage more than 5ml per hour
Platelet count below 50,000 per microlitre 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percantage of people diagnosed with ICU acquired weakness based on MRC sum score
Report at what day the patient developes weakness 		 First recording when the participant obeys 5 standardized questions which is followed by every day till the patient develops weakness or is discharged or discharged against medical advice or stops following commands or death 
 
Secondary Outcome  
Outcome  TimePoints 
Number of days on mechanical ventilator, ICU stay  When one of these events occur the patient develops weakness or is discharged or discharged against medical advice or stops following commands or death 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2022 
Date of Study Completion (India) 00/00/0000 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 00/00/0000 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   ICU acquired weakness is commonly seen in patients who are admitted to the ICU. It is associated with prolonged ICU stay or patients on mechanical ventilation for a longer duration. This lead to poor progression of the patient. A routine assessment for muscle strength is not done in an intensive care unit. Hence the early diagnosis of ICU acquired weakness is often missed and the chances of complications increase. Assessing muscle strength in a regular routine may help to determine the plan of treatment at the beginning if muscle weakness is acquired. This may help to guide further interventions for ICU acquired weakness. Patients will be screened according to the selection criteria. MRC sum score will be performed on these patients. There are six group of muscles that will be tested on both sides. Score will be given from one to five depending upon the grading of the scale. A score less than forty eight will be considered to be cut off for ICU acquired weakness. Muscle strength assessment will be carried out daily till the patient develops weakness or is discharged or is discharged against medical advice. The score will be noted in the data collection sheet. Data will be analyzed at the end of the study period.


 
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