| CTRI Number |
CTRI/2024/10/074645 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Early Warning Score oxygen for predicting requirement the mechanical ventilation in patients coming to the emergency department with shortness of breath: a prospective observational study |
|
Scientific Title of Study
|
Early Warning Score 02 for predicting the ventilatory requirement in patients with dyspnea presenting to the emergency department: a prospective observational study |
| 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 Upendra Hansda |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Trauma and Emergency, AIIMS Bhubaneswar, Sijua, Patrapada, Khordha, Odisha.
Khordha ORISSA 751019 India |
| Phone |
9437365720 |
| Fax |
|
| Email |
uhansdah@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Upendra Hansda |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Trauma and Emergency, AIIMS Bhubaneswar, Sijua, Patrapada, Khordha, Odisha.
ORISSA 751019 India |
| Phone |
9437365720 |
| Fax |
|
| Email |
uhansdah@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aashish Kumar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Trauma and Emergency, AIIMS Bhubaneswar, Sijua, Patrapada.
Khordha ORISSA 751019 India |
| Phone |
8789230920 |
| Fax |
|
| Email |
kaashish292@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Trauma and Emergency, AIIMS Bhubaneswar At- Sijua
PO- Patrapada
Dist- Khordha
Odisha, India
PIN- 751019 |
|
|
Primary Sponsor
|
| Name |
Dr Aashish Kumar |
| Address |
Department of Trauma and Emergency
At- Sijua
PO- Patrapada
Dist- Khordha
Odisha, India
PIN- 751019 |
| 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 Aashish Kumar |
AIIMS Bhubaneswar |
Green Zone, Emergency Department, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar. Khordha ORISSA |
8789230920
kaashish292@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R060||Dyspnea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
The Patient with dyspnea presented to the Emergency Department. |
|
| ExclusionCriteria |
| Details |
Cardiac arrest on arrival, trauma patients and the patients referred within 6 hours of arrival from the Emergency Department of AIIMS Bhubaneswar to another health centre. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Requirement of ventilatory support at 6 hours of presentation. |
6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="223" Sample Size from India="223"
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)
|
07/10/2024 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Clinical deterioration of patients is often preceded by worsening vital signs. If identified early and acted upon quickly, it is conjectured that further deterioration can be prevented. It is a system to identify at-risk patients early, and a treatment protocol to escalate care appropriately and determine the level of competency of the provider. Despite wide dissemination of Early Warning Scores and similar systems serious adverse events presaged by deteriorating vital signs continue to be a major source of morbidity. This is either due to inherent inadequacies of EWS, lack of adherence to the treatment protocol, or a combination of both. Many scoring systems are present all over the world to detect patient clinical worsening for example (National Early Warning Score (NEWS) and its updated version NEWS2, Modified Early Warning Score (MEWS), Rapid Acute Physiological Score (RAPS), and Cardiac Arrest Risk Triage (CART). These scores primarily aim to detect clinical deterioration in patients by tracking their vital signs, with high EWS scores triggering a response to prevent any potential clinical decline. It has been observed that patients’ vital signs usually change before any clinical deterioration. Consequently, if early and timely interventions are adequately performed, adverse outcomes for patients may be prevented. Warning scores provide a good and reliable source for pre-hospital settings and are easy to calculate and apply. In the NEWS scoring system, the score is calculated whether the oxygen requirement is there or not. However, it does not consider how much oxygen flow requirement is there. It takes the same score for a patient requiring oxygen flow of 2 L/min and 12 L/min. So, an accurate status of the patient is missed. The Early Warning Score O2 score includes the level of oxygen flow required to calculate the score. To assess the accuracy of a new tool Early Warning Score with O2 requirement may prove to be a better tool to predict clinical deterioration and will be easy to calculate and apply so that every healthcare professional can predict the outcome and intervene early to prevent the unfavourable outcome even in pre-hospital setting along with hospitalized and ICU setting. Designing an easily calculable score can benefit every level of healthcare and help triage patients who require mechanical ventilation. While anticipating the clinical deterioration the resources could be used in a well-versed manner. |