| CTRI Number |
CTRI/2024/11/077451 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Critical Care Pathway] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Critical care pathway to improve postoperative patient outcomes who undergone total knee replacement surgery |
|
Scientific Title of Study
|
A study to evaluate the efficacy of critical care pathway on patient outcome among postoperative patients undergone total knee replacement surgeries in tertiary care hospital, Gorakhpur: A randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Liya S |
| Designation |
M.Sc.Nursing Student |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Office no:1
College Of Nursing
4th Floor
MNC Building
AIIMS Gorakhpur
Kunraghat
Uttar Pradesh
Room no :1
College Of Nursing
4th Floor
MNC Floor
AIIMS Gorakhpur
Kunraghat
Uttar Pradesh
273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7012699863 |
| Fax |
|
| Email |
liya2000alphonsa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renuka K |
| Designation |
Professor Cum Principal |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Faculty Room No :1
Principal Office
4th Floor
MNC Building
College Of Nursing
AIIMS Gorakhpur
Kunraghat
Gorakhpur
Uttar Pradesh
College Of Nursing
AIIMS Gorakhpur
Kunraghat
Uttar Pradesh
273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7012699863 |
| Fax |
|
| Email |
renukagugan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renuka K |
| Designation |
Professor Cum Principal |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Room No: 1
4th Floor
College Of Nursing
MNC Building
AIIMS Gorakhpur
Kunraghat
Uttar Pradesh
Room No:2
4th Floor
College Of Nursing
MNC Building
AIIMS Gorakhpur
Kunraghat
Uttar Pradesh
273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7012699863 |
| Fax |
|
| Email |
renukagugan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| College Of Nursing
AIIMS Gorakhpur
Kunraghat
Uttar Pradesh
pin: 273008 |
|
|
Primary Sponsor
|
| Name |
Liya S |
| Address |
All Institute Of Medical Sciences, College Of Nursing,
Gorakhpur
Uttar Pradesh
Pin Code: 273008 |
| 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 Renuka K |
All India Institute Of Medical Sciences , Gorakhpur |
1st Floor
Postoperative ward
Hospital Complex
MNC Building
All India Institute Of Medical Sciences
Gorakhur
Kunraghat
Uttar Pradesh
PIN:273008
Gorakhpur
UTTAR PRADESH |
9486537848
renukagugan@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee AIIMS Gorakhpur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Critical Care Pathway |
A critical care Pathway (CCP) is a clinical management tool that helps medical care providers coordinate the delivery of patient care for a particular case type or condition. Critical care pathway (CCP) is an approach for organizing the care process of a defined group of patients during a specified period. It aims to improve the quality of care, reduce risks, enhance patient satisfaction, and enhance efficiency. A critical care pathway is a multidisciplinary care plan that describes the flow of care provided to a patient admitted to the hospital for any illness till discharge. Critical care pathways are very useful in providing collaborative and coordinated care to patients and will help in easy recovery and early discharge. Thus it will help in reducing the burden of health care delivery services and will be able to provide quality healthcare services as per the needs of the population. In recent years, studies focused on testing critical care pathways for patients in the context of primary care are increasing.
The study aims to evaluate the efficacy of the critical care pathway among postoperative orthopedic patients admitted to tertiary care hospital ,Gorakhpur.The successfull implementation of critical care pathway in postoperative orthopedic patients enables to widening of the concept of this pathway to other departments of hospital. The pathway encourages multidisciplinary teamwork in the hospital setting and also reduces the length of stay of patients in the hospital. This will help to reduce health care burden in health care services. The critical care pathway will be administered for 7 days for one time. |
| Comparator Agent |
Routine care given after total knee replacement surgeries |
Routine care is given after total knee replacement surgeries are those care given by multidisciplinary care providers will be recorded in the patient file itself. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Postoperative Patients who have undergone total knee replacement surgeries
2. Patients whose age is more than 18 years. |
|
| ExclusionCriteria |
| Details |
1. Postoperative Patients who are critically ill
2. Postoperative patients who are admitted for more than one week. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be a significant difference in postoperative patient outcomes among patients undergoing total knee replacement surgeries in experimental and control groups. |
4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be a significant difference in postoperative patient outcomes among patients undergoing total knee with selected socio-demographic variables |
at baseline & 4th week |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2024 |
| Date of Study Completion (India) |
31/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A randomized controlled study was conducted at the All India Institute of Medical Sciences, Gorakhpur. The study samples were postoperative patients who had undergone total knee replacement surgeries. The sample size was 52, 26 in the experimental and control groups. The study followed the basic true experimental design—a post-test-only control group design. The target population was postoperative patients undergoing total knee replacement surgeries at AIIMS Gorakhpur.
The study will be conducted in the following steps: Phase 1: Participants were recruited, informed consent was obtained to participate in the study, and sociodemographic variables were collected on the first postoperative day.
Phase 2: The critical care pathway was administered to the participants in the experimental group for multidisciplinary care planning. For 5 postoperative days, patient care was planned using this critical care pathway, and the control group participants got routine care.
Phase 3: On the fifth postoperative day, postoperative patient outcomes like mobility, pain, wound healing status, and psychological status were assessed among patients in the experimental and control group. |