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CTRI Number  CTRI/2025/09/095041 [Registered on: 18/09/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Studying the ability of a new score (Delta POX-HR) to predict need for invasive oxygen therapy in ICU patients on High Flow Nasal Cannula (HFNC), suffering from Trauma. 
Scientific Title of Study   Ability of Delta POX-HR index score to predict HFNC outcome in trauma patients with Acute Hypoxemic Respiratory Failure (AHRF): 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  Babita Gupta 
Designation  Professor 
Affiliation  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, New Delhi
1st Floor, Faculty Offices, JPNATC, AIIMS, New Delhi
South
DELHI
110029
India 
Phone  9818302776  
Fax    
Email  drbabitagupta@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Babita Gupta 
Designation  Professor 
Affiliation  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, New Delhi
1st Floor, Faculty Offices, JPNATC, AIIMS, New Delhi
South
DELHI
110029
India 
Phone  9818302776  
Fax    
Email  drbabitagupta@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Yash Mishra 
Designation  Junior Resident (Academic) 
Affiliation  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  7830475048  
Fax    
Email  mishradec24yash@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi, 110029 
 
Primary Sponsor  
Name  Babita Gupta 
Address  Department of Anesthesiology, Pain Medicine and Critical Care, JPNATC, AIIMS, New Delhi, India, PIN 110029 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Anesthesiology Pain Medicine and Critical Care  AIIMS, Ansari Nagar, New Delhi 110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Babita Gupta  Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi  TC-2 and TC-2A General ICU, 2nd Floor, Trauma Center Ward Block, Jai Prakash Narayan Apex Trauma Center, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
South
DELHI 
9818302776

drbabitagupta@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for PG Research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J960||Acute respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All adult patients aged 18-65 years, admitted in ICU requiring HFNC for AHRF. 
 
ExclusionCriteria 
Details  1) Patients requiring intubation for surgical procedures.

2) Patients receiving HFNC therapy after extubation.

3) Patients with DNR orders.

4) Patients requiring readmission to ICU and initiated on HFNC therapy.

5) Patients who may require urgent intubation within two hours after HFNC initiation or require ET intubation.

6) Patients who are receiving NIV and HFNC alternately.

7) Refusal of Patient or Patient’s attendants (in case patient is unable to) to consent to study.

8) Patients on Beta-blockers, Beta agonists, alpha-2 agonists, amiodarone, CCB, digoxin or alpha-2 agonists.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Escalation of HFNC (to NIV / Intubation defined as HFNC Failure) predicted using Delta POX-HR at 3 hours
 
3 hours after HFNC Initiation 
 
Secondary Outcome  
Outcome  TimePoints 
Escalation of HFNC (to NIV / Intubation defined as HFNC Failure) predicted using Delta POX-HR at 12 hours
 
12 hours after HFNC Initiation 
Escalation of HFNC (to NIV / Intubation defined as HFNC Failure) predicted using Delta POX-HR at 24 hours
 
24 hours after HFNC Initiation 
Escalation of HFNC (to NIV / Intubation defined as HFNC Failure) predicted using Delta POX-HR at 48 hours
 
48 hours after HFNC Initiation 
 
Target Sample Size   Total Sample Size="207"
Sample Size from India="207" 
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)   28/09/2025 
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="2"
Months="0"
Days="0" 
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  

This study is an Observational, Single Center study to evaluate Ability of ∆POX-HR index score to predict HFNC outcome in trauma patients admitted in ICU by comparing the scores of patients categorized as HFNC Success (no need for escalating oxygen therapy from HFNC to NIV/Intubation within 48 hours of initiation) and HFNC Failure (need for escalating oxygen therapy from HFNC to NIV/Intubation within 48 hours of initiation). We hypothesize that Delta POX-HR is a better index for predicting HFNC Success than POX-HR, Delta ROX and ROX index. The primary outcome is predicting requirement of NIV / Intubation after 48 hours (HFNC Failure) using Delta POX-HR at 3 hours after HFNC initiation. The secondary outcomes are predicting requirement of NIV / Intubation after 48 hours (HFNC Failure) using Delta POX-HR at 12, 24 and 48 hours after HFNC initiation.
 

ROX index is a known predictor of intubation requirement after HFNC. Recent studies have shown superiority of POX-HR and Delta POX-HR over ROX index in predicting intubation requirement after HFNC. Most previous studies comparing new indices were conducted during a period marked by high rates of AHRF due to COVID-19. Predictive ability of these indices in Trauma patients having AHRF requiring HFNC has not been validated.

Initiation of HFNC therapy, need for intubation or NIV, or decision to wean a patient off HFNC will be made by the physicians attending to the patient guided by institute protocol but based on clinical assessment on a case-by-case basis keeping patient’s vitals, pH, PaO2, effort tolerance and comfort in view, to ensure the subjects of the study receive the same standard of therapy as regular ICU patients.

The guideline for weaning a patient off HFNC followed will be as per Institute protocol i.e.

  •  Patients requiring HFNC therapy will be initiated at 60 L/min of 100% O2 targeting SpO2 > 94%. 
  • Once patient is comfortable (Decreased RR and accessory muscle use) and SpO2 is stabilized at 94%, FiO2 will be decreased by 5% till 60% is reached.
  • Once FiO2 is approximately equal to 60%, flows will be reduced by 10 L/min till they reach 30 L/min.
  • Then FiO2 is to be reduced till 30 - 40% and the patient is switched to standard O2 therapy via Face mask thereafter as per institutional protocol.

Adult patients admitted in Trauma Center (JPNATC) General ICUs with AHRF and requiring HFNC that also fulfil all inclusion and exclusion criteria will be recruited for the study. Relevant data for the study will be collected, namely their demographics, vitals and ABG values at five time points (before HFNC initiation, and 3, 12, 24, 48 hours after initiation of HFNC) along with other information during their admission. Data is then used to calculate various indices. (ROX, POX, ROX-HR, POX-HR and their dynamic counterparts calculated by subtracting the initial score from a score at time t). These indices will be analysed and compared in their predictive value. The data collected will be classified as qualitative (or nominal or categorical) and quantitative (or ordinal) described using appropriate tools like Mean (SD) and Frequency (Percentages) respectively. Categorical variables will be compared using the Chi-square test. Non-parametric data was reported as median (interquartile range, IQR) and compared using the median test. Cut-offs for the various indices, rounded off to the nearest 0.01, will be chosen to maximize the sum of sensitivity and specificity based on the receiver operating characteristic (ROC) curves (to satisfy the highest value for Youden index). From these cut-offs, Kaplan–Meier (KM) plots for HFNC success were determined and compared using the log-rank test. Univariate and multivariate Cox proportional regression analysis will be performed to evaluate POX-HR indices. Statistical difference will be considered significant at p ≤ 0.05.


 
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