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CTRI Number  CTRI/2026/02/104971 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study comparing hand mittens and wrist restraints in patients admitted to Intensive Care Unit (ICU) 
Scientific Title of Study   A prospective, observational study comparing mittens versus wrist restraints in critically ill patients. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akhila Bollineni Kumarendra 
Designation  DrNB Trainee - Critical Care Medicine  
Affiliation  Apollo Hospitals, Greams Road, Chennai. 
Address  Department of Critical Care Medicine, Apollo Hospitals, Greams lane, off Greams Road, Chennai.

Chennai
TAMIL NADU
600006
India 
Phone  9003185465  
Fax    
Email  bollineniakhila@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ajay Padmanaban 
Designation  Senior Consultant  
Affiliation  Apollo Hospitals, Greams Road, Chennai. 
Address  Department of Critical Care Medicine, Apollo Hospitals, Greams lane, off Greams Road, Chennai.

Chennai
TAMIL NADU
600006
India 
Phone  9840264784  
Fax    
Email  ajaypadmanaban@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Akhila Bollineni Kumarendra 
Designation  DrNB Trainee - Critical Care Medicine  
Affiliation  Apollo Hospitals, Greams Road, Chennai. 
Address  Department of Critical Care Medicine, Apollo Hospitals, Greams lane, off Greams Road, Chennai.

Chennai
TAMIL NADU
600006
India 
Phone  9003185465  
Fax    
Email  bollineniakhila@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Apollo Main Hospital 
Address  21 Greams Lane, Off Greams Road, Chennai, Tamil Nadu - 600006 India 
Type of Sponsor  Private hospital/clinic 
 
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 
Dr Akhila Bollineni Kumarendra  Apollo Hospitals  Multidisciplinary critical care unit, Apollo Hospitals, 21, Greams Lane, Off Greams Road, Thousand Lights, Chennai.
Chennai
TAMIL NADU 
09003185465

bollineniakhila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - biomedical research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All consenting adults admitted to the multidisciplinary ICU.
2. Patients who require the application of physical limb restraints ( mittens or wrist restraints) for the first time during their ICU admission. 
 
ExclusionCriteria 
Details  Patients will be excluded from the study if they meet any of the following criteria:
1. Patients admitted for an expected ICU stay of less than 24 hours (e.g., for routine
post-operative recovery).
2. Patient or family refusal to consent for the clinical application of physical restraints. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Comparison of incidence of unplanned device removal
2. Comparison of incidence of restraint site injury 
From the time of restraint application until ICU discharge or removal of restraints, whichever is earlier. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of sedation requirement
2. Comparison of sedation-free days 
From the time of restraint application until ICU discharge or removal of restraints, whichever is earlier. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   17/03/2026 
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   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 prospective observational study conducted in the Intensive Care Unit of a tertiary care hospital. The study aims to compare mittens and wrist restraints in critically ill adult patients who require physical limb restraints as part of routine ICU care. All consecutive adult patients of age 18 years and above, who require physical restraints for the first time during their ICU admission will be included in the study during the study period. Patients expected to have an ICU stay of less than 24 hours will be excluded.                                      

                       The primary outcomes are incidence of unplanned device removal and incidence and severity of restraint site injury assessed using a standardized grading scale. Secondary outcomes include total daily dose of sedative and analgesic medications and number of sedation-free days during the restraint period. Data will be collected prospectively from routine clinical and nursing records without any modification of patient management. Each patient will be followed until discontinuation of restraints, ICU discharge, or death, whichever occurs first.



 
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