| CTRI Number |
CTRI/2024/11/076352 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Survey |
| Study Design |
Other |
|
Public Title of Study
|
Pressure Injury Prevention Survey in Indian ICUs |
|
Scientific Title of Study
|
Pressure Injury Prevention Survey in Indian ICUs PIPSII |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA
122001
India |
| Phone |
9818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA
122001
India |
| Phone |
9818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA
122001
India |
| Phone |
9818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Medanta The Medicity Institute of Critical Care and Anesthesiology Sector 38 Gurgaon Haryana 122001 |
|
|
Primary Sponsor
|
| Name |
Dr. Deepak Govil |
| Address |
Medanta The Medicity Institute of Critical Care and Anesthesiology Sector 38 Gurgaon Haryana 122001 |
| 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 |
| Dr Deepak Govil |
Medanta The Medicity |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA |
09818056688
drdeepak_govil@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Any healthcare worker working in Indian ICU. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevention strategies for PI in ICU patients will be developed by interdisciplinary expert panel using validated consensus method |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identify factors affecting implementation of pressure injury prevention strategies |
Six months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A Pressure Injury (PI) is defined as localised damage to skin and/or underlying tissues, as a result of pressure or pressure in addition to shear. PI are usually common over bony prominences but may also be associated with a medical device, termed as medical device related PI ( MDRPI). Aim of this study is to ascertain current practices with regard to Pressure Injury Prevention in Indian ICUs and establishing best practice recommendations. This is a multi centric survey. There will be no direct patient contact or intervention. Study objective is To gather data on practices prevalent with regard to pressure injury prevention and To identify factors affecting implementation of pressure injury prevention strategies. A Delphi technique will be used in our PIP survey. An interdisciplinary panel of experts will be convened, which will consist of a minimum 15 participants. This study will use an iterative, anonymous, multistage approach with controlled feedback to develop a consensus based criteria. Study duration is six months.
|