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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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 preventedIt 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.

 
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