| CTRI Number |
CTRI/2024/07/069913 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Quasi- Experimental study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Effectiveness and Feasibility of Modified Early Warning Signs (MEWS) score among cardiac patients |
|
Scientific Title of Study
|
A quasi
experimental study to assess the effectiveness and feasibility of using Modified Early Warning Signs (MEWS)score on early detection of
adverse cardiac signs on selected outcome variables among cardiac
patients in Advanced Cardiac Centre, PGIMER, Chandigarh,2023 – 25 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VANITHA A |
| Designation |
MSc Nursing Student |
| Affiliation |
Department of Nursing, National Institute of Nursing Education, PGIMER, Chandigarh -160012 |
| Address |
MSc Nursing (Medical surgical Nursing specialty),Department of Nursing, National Institute of Nursing Education, PGIMER,Sector-12,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7010739359 |
| Fax |
|
| Email |
vanithaaru593@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti |
| Designation |
Associate Professor |
| Affiliation |
Department of Nursing, National Institute of Nursing Education, PGIMER, Chandigarh -160012 |
| Address |
Department of Nursing, National Institute of Nursing Education, PGIMER,Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7010739359 |
| Fax |
|
| Email |
shrutipgi2011@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
VANITHA A |
| Designation |
MSc Nursing Student |
| Affiliation |
Department of Nursing, National Institute of Nursing Education, PGIMER, Chandigarh -160012 |
| Address |
MSc Nursing (Medical Surgical Nursing Specialty), Department of Nursing, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7010739359 |
| Fax |
|
| Email |
vanithaaru593@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VANITHA A |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh-160012 |
| 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 |
| VANITHA A |
Advance Cardiac Centre, Post Graduate Institute of Medical Education and Research, Chandigah |
Department of Cardiology, Cardiology A and B blocks (ward), 3rd floor
Chandigarh
CHANDIGARH |
7010739359
vanithaaru593@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21A||Other type of myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria includes the both adult male and female from the age group of 18 years with the selected cardiac patients who are all under high risk of deterioration. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for this study includes the selected cardiac patients below 18 years of age and the cardiac patients who died within 24 hours of admission and the patients who had cardiac arrest at the time of admission |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Checking the feasibility of using MEWS score among the cardiac patients and its effectiveness, patient safety and quality of care |
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the care escalation, in hospital cardiac arrest & timely intervention initiation |
6Weeks |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
17/07/2024 |
| 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="2"
Days="30" |
|
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
|
A quasi experimental design is using to identify the feasibility and effectiveness of Modified Early Warning Signs (MEWS) score among the cardiac patients by estimated sample size of 154. In which experimental group 77 and control group will be 77. Control group will receive the as usual routine care where as experimental group will monitored with the help of MEWS score and with routine care. Assessing the outcome variables such as feasibility, timely initiation of treatment, care escalation, patient safety and quality of care and also assessing the in hospital cardiac arrest. |