| 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
|
|
|
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.
|