| CTRI Number |
CTRI/2025/12/099071 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The impact of new early warning score on patient management and workload management of hospital staff |
|
Scientific Title of Study
|
Implementation and Evaluation of the National Early Warning Score 2 (NEWS2) System in a tertiary care hospital – A prospective mixed methods study. |
| Trial Acronym |
IMPNEWS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vipin Sukumaran |
| Designation |
Assistant professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology & Critical care Armed forces medical college AFMC Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7420065560 |
| Fax |
|
| Email |
vipinsukumaran83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipin Sukumaran |
| Designation |
Assistant professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology & Critical care Armed forces medical college AFMC Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7420065560 |
| Fax |
|
| Email |
vipinsukumaran83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vipin Sukumaran |
| Designation |
Assistant professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology & Critical care Armed forces medical college AFMC Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7420065560 |
| Fax |
|
| Email |
vipinsukumaran83@gmail.com |
|
|
Source of Monetary or Material Support
|
| ARMED FORCES MEDICAL COLLEGE
(A.F.M.C), wanowrie, Pune, Maharashtra, PIN - 411040 |
|
|
Primary Sponsor
|
| Name |
ARMED FORCES MEDICAL COLLEGE |
| Address |
Department Of Anaesthesiology & Critical Care, Armed Forces Medical College, Pune, Maharashtra, Pin - 411040 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Vipin Sukumaran |
Department of anaesthesiology & critical care |
Command hospital southern command Pune Maharashtra - 411040
Pune
MAHARASHTRA |
7420065560
vipinsukumaran83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMED FORCES MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, (2) ICD-10 Condition: R651||Systemic inflammatory response syndrome (SIRS) of non-infectious origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted to the acute wards of a tertiary care hospital will be included in the study |
|
| ExclusionCriteria |
| Details |
Patients admitted directly to ICU
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In hospital mortality after implementation of NEWS2 Score in the acute wards of a tertiary care hospital |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ICU transfer rates and increase in workload among health care workers |
6 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
25/12/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
NEWS2 SCORE WILL BE IMPLEMENTED IN THE ACUTE WARDS OF A TERTIARY CARE HOSPITAL. WE WILL EVALUATE THE INHOSPITAL MORTALITY, ICU TRANSFER RATES AND WORKLOAD EFFECTS AFTER THE IMPLEMENTATION OF NEWS2 SCORE IN THE HOSPITAL. |