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CTRI Number  CTRI/2023/09/057318 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 06/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to assess the ability of certain indices to predict the failure of high flow nasal cannula oxygen therapy when used for respiratory failure due to low oxygen levels. 
Scientific Title of Study   Predictive ability of ROX index, ROX-HR and HACOR Scale for High Flow Nasal Cannula Failure in Patients with Acute Hypoxemic Respiratory Failure: 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 Saurabh Taneja 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Institute of Critical Care Medicine, 4th Floor, SSRB Building, Sir Ganga Ram Hospital, New Delhi

New Delhi
DELHI
110060
India 
Phone  9811538315  
Fax    
Email  dr.saurabhtaneja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dileep N 
Designation  DrNb Critical Care Medicine Trainee 
Affiliation  Sir Ganga Ram Hospital 
Address  Institute of Critical Care Medicine, 4th Floor, SSRB Building, Sir Ganga Ram Hospital, New Delhi

New Delhi
DELHI
110060
India 
Phone  8095199900  
Fax    
Email  dileepzeon@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dileep N 
Designation  DrNb Critical Care Medicine Trainee 
Affiliation  Sir Ganga Ram Hospital 
Address  Institute of Critical Care Medicine, 4th Floor, SSRB Building, Sir Ganga Ram Hospital, New Delhi


DELHI
110060
India 
Phone  8095199900  
Fax    
Email  dileepzeon@gmail.com  
 
Source of Monetary or Material Support  
Institute of Critical Care Medicine, 4th Floor, SSRB Building, Sir Ganga Ram Hospital, New Delhi - 110060 
 
Primary Sponsor  
Name  Dr Saurabh Taneja 
Address  Institute of Critical Care Medicine, 4th Floor, SSRB Building, Sir Ganga Ram Hospital, New Delhi - 110060 
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 Saurabh Taneja  Sir Ganga Ram Hospital  Intensive Care Unit, Institute of Critical Care Medicine, 4th Floor, SSRB Building, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi - 110060
New Delhi
DELHI 		 9811538315

dr.saurabhtaneja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients above 18 years of age.
2. Both males and females. 
 
ExclusionCriteria 
Details  1. Patients with an history of asthma or an exacerbation of chronic obstructive pulmonary
disease (COPD).
2. Patients on domiciliary oxygen therapy for more than 7 days.
3. Absence of commitment to pursue full life support measures (Do-not-intubate or Do-not-
resuscitate orders).
4. Glasgow coma scale < 12.
5. Epistaxis, facial trauma, or recent nasal/facial surgery.
6. Refusal to consent for the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Failure of HFNC therapy as evidenced by the need of upgradation of respiratory support
to mechanical ventilation noninvasive or invasive 		 At 6 & 12 hours after initiation of HFNC 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  0 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   18/09/2023 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dileepzeon@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 01-09-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Acute hypoxemic respiratory failure is one of the most common life-threatening conditions that  warrants immediate medical attention and intensive care admission, with substantial morbidity and  mortality. Of late, there is an increasing usage of the high flow nasal cannula as a primary mode  of oxygenation in patients with acute hypoxemic respiratory failure, bolstered by recent evidence  that demonstrated reduced rates of intubation and invasive mechanical ventilation, with possibly  reduced mortality. It has emerged as an alternative to non-invasive mechanical ventilation due to  its reported advantages of better patient comfort, tolerability, improved oxygenation parameters  and decreased work of breathing in respiratory failure. However, it is also widely known that delay  in intubation and institution of invasive mechanical ventilation may worsen patient outcomes in  acute hypoxemic respiratory failure. No clear recommendations or criteria have been established  to identify the patients who need invasive mechanical ventilation. Hence, there is a need to identify  characteristics that can predict failure of high flow nasal cannula therapy, so that such subset of  patients may be monitored strictly and kept under consideration for early endotracheal intubation,  which may potentially improve patient outcomes.
The ROX index, ROX-HR and the HACOR scale are some of the novel indices that have been  demonstrated to predict the failure of high flow nasal cannula therapy. These values are obtained  from commonly measured bedside parameters. However, the evidence is scant and needs more  validation. 
This study will be a prospective observational study conducted in the Medical- Surgical intensive  care unit of Sir Ganga Ram Hospital, New Delhi. We plan to recruit approximately 80 subjects in  this study and aim to test the ability of these three indices to predict the failure of high flow nasal  cannula therapy when used as the primary mode of oxygenation in the first 12 hours of initiation

 
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