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CTRI Number  CTRI/2021/02/031346 [Registered on: 17/02/2021] Trial Registered Prospectively
Last Modified On: 06/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Application of ROX index and ROX-HR index as predictors of response to high flow nasal oxygenation in post extubation respiratory failure 
Scientific Title of Study   Application of ROX index and ROX-HR index as predictors of response to high flow nasal oxygenation in post extubation respiratory failure 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naveen Chandra Chinni 
Designation  Senior resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of anaesthesia, pain medicine and critical care, Teaching block, AIIMS, Ansari Nagar South Delhi

South
DELHI
110029
India 
Phone  9505552607  
Fax    
Email  nav5mims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Darlong V 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain Medicine and Critical care Teaching block AIIMS Ansari Nagar South DELHI DELHI

South
DELHI
110029
India 
Phone  9868397809  
Fax    
Email  darlongv@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Darlong V 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain Medicine and Critical care Teaching block AIIMS Ansari Nagar South DELHI DELHI

West
DELHI
110029
India 
Phone  9868397809  
Fax    
Email  darlongv@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  All India Institute of Medical Sciences Ansari nagar NEW DELHI 
Type of Sponsor  Government medical college 
 
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 
Naveen Chandra Chinni  All India Institute Of Medical Sciences  Department of Anaesthesiology, Pain medicine and Critical care AIIMS
South
DELHI 		 9505552607

nav5mims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committe, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Respiratory failure within 48hrs post extubation requiring non invasive respiratory support (i.e., High flow nasal oxygenation) 
 
ExclusionCriteria 
Details  Age < 18yrs
Elective intubation for therapeutic or diagnostic purposes
Do not intubate orders
Accidental extubation
Presence of hypercapnia (PaCO2 > 45 mmHg)
Acute respiratory failure secondary to asthma
Chronic obstructive pulmonary disease (COPD) exacerbation
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate utility of ROX index and ROX-HR index in predicting HFNC outcome (success/failure) in post extubation respiratory failure in patients in ICU  To evaluate utility of ROX index and ROX-HR index in predicting HFNC outcome (success/failure) in post extubation respiratory failure in patients in ICU 
 
Secondary Outcome  
Outcome  TimePoints 
To identify if ROX index and ROX HR can predict

1.ICU mortality
2.ICU length of stay
3.HFNC outcome in combination with number of quadrants involved in chest xray and lung aeration score
 		 till discharge from ICU 
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
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)   21/02/2021 
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   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   In the past years, nasal high flow (NHF) oxygenation has gained popularity among intensivists to manage patients with acute respiratory failure, filling a gap in the ventilator support escalation between facemask oxygen and noninvasive or invasive mechanical ventilation. It is an attractive alternative to non-invasive ventilation (NIV) or conventional oxygen therapy because of its reported advantages in patient comfort, improved oxygenation, and decreased work of breathing in respiratory failure .

There is an increasing use of high flow nasal cannula oxygen therapy (HFNC) for acute hypoxemic respiratory failure, encouraged by evidence suggesting reduced intubation rates and possibly lower mortality .A unique feature of HFNC is its ability to comfortably deliver high flows of warmed humidified gas, 20–70 L/ min, with a FiO2 range of 0.21–1.0. Physiological responses to NHF therapy include increases in airway pressure, end-expiratory lung volume (EELV), and oxygenation which are probably optimal with higher flows (60–70 L/min), while the effects on dead-space washout, work of breathing, and respiratory rate may be obtained with intermediate flows (20–45 L/min).

The ROX (respiratory rate oxygenation) index, a ratio of pulse oximetry/fraction of inspired oxygen to respiratory rate per minute (SpO2/FiO2/RR), has been validated to predict HFNC success in patients with pneumonia and acute respiratory failure . It is easily derived from commonly recorded variables measured in a noninvasive manner. ROX-HR (respiratory rate oxygenation-heart rate) index, the ratio of ROX index over HR (beats/min) and multiplying by a factor of 100 has been tried as predictor and has shown promising results in the early identification of patients who are at high risk of HFNC failure and for patients initiated on HFNC for acute respiratory failure as well as a preventative strategy after a planned HFNC following extubation. However largerer validation studies are needed to establish the role of the ROX-HR index in patients on HFNC.

             Extubation failure occurs in 10-20% of ICU patients and is associated with extremely poor outcomes including high mortality rates of 25 to 50% . Delayed intubation is associated with mortality. There is growing use of HFNC in post extubation failure. Although many respiratory (oxygenation, respiratory rate, thoraco-abdominal asynchrony) and non respiratory (need for vasopressors, baseline Sequential Organ Failure Assessment score, severity of disease) criteria have been found to be associated with HFNC failure, none of them has been tested prospectively to predict HFNC outcome after extubation failure. Patients identified as having a high risk of HFNC failure should be closely monitored or considered for early intubation, which may potentially improve patient outcomes. 

 ROX index and ROX–HR index have not been evaluated in patients with extubation failure. Therefore in this study we plan to evaluate the efficacy of ROX and ROX-HR index, in predicting HFNC failure in patients initiated on HFNC due to post-extubation respiratory failure

REFERENCES

1.   1.Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, et al. Physiologic effects of high-flow nasal cannula in acute hypoxemic respiratory failure. Am J Respir Crit Care Med. 2017;195:1207–15.

2.    2. Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, et al. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. NEngl J Med. 2015;372:2185–96.

3.    3.Corley A, Caruana LR, Barnett AG et al (2011) Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth 107:998–1004.

4.     4. .Bräunlich J, Köhler M, Wirtz H (2016) Nasal highflow improves ventilation in patients with COPD. Int J Chron Obstruct Pulmon Dis 11:1077–

5.     5. Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernández G, et al. An index combining      respiratory rate and oxygenation to  predict outcome of nasal high-flow therapy. Am J        Respir Crit Care Med. 2019;199:1368–76.

6.      6. Goh, K.J., Chai, H.Z., Ong, T.H. et al. Early prediction of high flow nasal cannula therapy outcomes using a modified ROX index incorporating heart rate. j intensive care 8, 41 (2020).

7.     7. Thille A, Richard JC, Brochard L, et al: The decision to extubate in the Intensive Care Unit. Am J Resp Crit Care Med 2013, 187:1294-1302.

8.      8.Frat JP, Thille AW, Mercat A et al (2015) High-flow oxygen throughnasal cannula in acute hypoxemic respiratory failure. N Engl J Med372(23):2185–2196

9.   9.García-de-Acilu M, Marin-Corral J, Vázquez A et al (2017) Hypoxemic patients with bilateral infiltrates treated with high-flow nasal cannula present a similar pattern of biomarkers of inflammation and injury to acute respiratory distress syndrome patients. Crit Care Med 45:1845–1853

1010. Messika J, Ben Ahmed K, Gaudry S et al (2015) Use of high-flow nasal cannula oxygen therapy in subjects with ARDS: a 1-year observational study. Respir Care 60:162–169

1111.Bräunlich J, Dellweg D, Bastian A et al (2019) Nasal high-flow versus noninvasive ventilation in patients with chronic hypercapnic COPD. COPD 14:1411–1421

1212.Frat J-P, Ricard J-D, Quenot J-P et al (2019) Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med 7:303–312








 
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