| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|