| CTRI Number |
CTRI/2024/03/064872 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The study of factors affecting prevention & management of bedsore in ICU patients with nurse education based care in two tertiary care teaching hospitals in coastal Karnataka. |
|
Scientific Title of Study
|
Burden of hospital-acquired pressure injuries (HAPI’s) and the effects of a nurse-led hapi prevention bundle on the outcomes of pressure injuries among critically ill patients in two tertiary care teaching hospitals in coastal Karnataka.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Prasannakumara |
| Designation |
Nurse Practitioner-Critical Care |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Medical-Surgical Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9060186606 |
| Fax |
|
| Email |
pk9518brahmavar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elsa Sanatombi Devi |
| Designation |
Director, M-FILIIPE (FRI), MAHE, Manipal Deputy Director, CCEID, MAHE, Manipal, Professor and QMR |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Medical-Surgical Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9901960496 |
| Fax |
|
| Email |
elsa.sana@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suba sooria P |
| Designation |
Head of Nursing services |
| Affiliation |
Kasturba Medical College MAHE Manipal |
| Address |
Head of Nursing Services Department, Kasturba Hospital Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9745388223 |
| Fax |
|
| Email |
suba.sooria@manipal.edu |
|
|
Source of Monetary or Material Support
|
| The study will be conducted at Kasturba Hospital Manipal and Kasturba Medical College Attavar, Mangalore, which will provide the infrastructural support for the same. |
|
|
Primary Sponsor
|
| Name |
Mr Prasannakumara |
| Address |
Manipal College of Nursing Manipal Academy of Higher Education Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr Prasannakumara |
Kasturba Hospital, Manipal |
Department of Critical Care, Intensive Care Unit-1, 2 and 3, 1st floor, Udupi - Hebei Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9060186606
pk9518brahmavar@gmail.com |
| Mr Prasannakumara |
KMC Hospital Attavar |
Intensive Care Unit, Nandi Gudda Rd, Attavar, Mangalore, Karnataka 575001
Dakshina Kannada
KARNATAKA |
9060186606
pk9518brahmavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Institutional Ethics Committee |
Approved |
| Kasturba Medical College, Mangalore Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hospital Acquired Pressure Injuries |
| Patients |
(1) ICD-10 Condition: L89||Pressure ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intensive Care Patients (With HAPI Prevention Bundle) |
To assess the effectiveness, and compliance of the HAPI prevention bundle and reduction in grade/stage in pressure injuries for 20 weeks |
| Intervention |
Intensive Care Patients (Without HAPI Prevention Bundle) |
To assess the Burden of HAPIs 20 weeks |
| Comparator Agent |
Intensive Care Unit Nurses (Post-Test) |
To assess the KAP and effectiveness of the HAPI prevention Bundle after 8 weeks of post-training. |
| Intervention |
Intensive Care Unit Nurses (Pre-test) |
To Assess the Knowledge, Attitude, and before training HAPI prevention Bundle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have been admitted to ICU expected to stay more than 24 hours
Nurses who work in the selected intensive care units (ICU), With at least six months of ICU experience
|
|
| ExclusionCriteria |
| Details |
Patients ICU observation patients admitted for less than 24 hours. Patients diagnosed with any stage of PIs in the first 24 hours of admission to the ICU.
Nurses who are not willing to participate in the study and Nursing trainee or nursing students. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the ICU nurses KAP before and after the introduction of the HAPIPB training Phase 2 (8 weeks) |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of 5% in proportion of HAPIs & time taken for changes in grade or stage of HAPIs of ICU patients after the implementation of HAPI bundle |
at the end of 20 weeks Phase 1
after introduction of Bundle 20 weeks Phase 3 |
|
|
Target Sample Size
|
Total Sample Size="656"
Sample Size from India="656"
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)
|
05/04/2024 |
| 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="3"
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
|
Burden of hospital-acquired pressure injuries (HAPI’s) and the effects of a nurse-led "HAPI prevention bundle" on the outcomes of pressure injuries among critically ill patients in two tertiary care teaching hospitals in coastal Karnataka. This study will adopt the Quasi-experimental design (PRE-POST), The population is patients who are admitted to the intensive care unit and then develop the new onset of hospital-acquired pressure injuries (HAPI’s) in males, and females aged between 18 to 99 years will be involved. During the first 20 weeks, the burden of HAPIs will be assessed, followed by pre-test knowledge will be assessed from ICU nurses and 8 weeks of training will be given for intensive care nurses based on inclusion and exclusion criteria. Introduce the HAPI prevention bundle to assess compliance and a Post-Test will be conducted then 20 weeks to assess whether the patients will get the benefits from the bundle which means reducing the proportion and grade/stages of pressure injuries. Administration permission has been taken from the college and ethical clearance from the institutional ethical committee.
|