| CTRI Number |
CTRI/2024/10/074936 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Application of HFNC] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare ROX index and HACOR scale for predicting success of high flow nasal cannula in patients with low oxygen respiratory failure. |
|
Scientific Title of Study
|
Comparison of ROX index with HACOR scale in predicting success of high-flow nasal cannula in acute hypoxemic respiratory failure. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejawat Kushal Kumar |
| Designation |
Resident doctor |
| Affiliation |
Vardhaman mahavir medical College and Safdarjung hospital |
| Address |
Pulmonary & critical care department.
Super speciality block, 6th floor
VMMC and Safdarjung hospital
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9785801961 |
| Fax |
|
| Email |
jimmytejawat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NK GUPTA |
| Designation |
Professor |
| Affiliation |
Vardhaman mahavir medical College and Safdarjung hospital |
| Address |
Pulmonary & critical care department.
Super speciality block, 6th floor
VMMC and Safdarjung hospital
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9350859929 |
| Fax |
|
| Email |
drgupta.nk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejawat Kushal Kumar |
| Designation |
Resident doctor |
| Affiliation |
Vardhaman mahavir medical College and Safdarjung hospital |
| Address |
Pulmonary & critical care department.
Super speciality block, 6th floor
VMMC and Safdarjung hospital
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9785801961 |
| Fax |
|
| Email |
jimmytejawat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pulmonary and critical care department.
Super speciality block, 6th floor
VMMC and SAFDARJUNG HOSPITAL
Ansari Nagar
New Delhi 110029
India |
|
|
Primary Sponsor
|
| Name |
VMMC and SAFDARJUNG HOSPITAL |
| Address |
Vardhaman mahavir medical College and Safdarjung hospital
Ansari Nagar
New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tejawat Kushal Kumar |
VMMC and SAFDARJUNG HOSPITAL |
Pulmonary and critical care department.
Super speciality block, 6th floor
VMMC and SAFDARJUNG HOSPITAL
Ansari Nagar
New Delhi 110029
New Delhi
DELHI |
9795801961
jimmytejawat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Safdarjung institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, (2) ICD-10 Condition: J80||Acute respiratory distress syndrome, (3) ICD-10 Condition: J471||Bronchiectasis with (acute) exacerbation, (4) ICD-10 Condition: J18||Pneumonia, unspecified organism, (5) ICD-10 Condition: J60-J70||Lung diseases due to external agents, (6) ICD-10 Condition: J09-J18||Influenza and pneumonia, (7) ICD-10 Condition: J80-J84||Other respiratory diseases principally affecting the interstitium, (8) ICD-10 Condition: J85-J86||Suppurative and necrotic conditions of the lower respiratory tract, (9) ICD-10 Condition: J90-J94||Other diseases of the pleura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application of high flow nasal cannula in patients with hypoxemic respiratory failure. |
Patient with hypoxemic respiratory failure arriving at department(RICU) will be assessed at 0 hrs for application of HFNC. HFNC will be terminated if any of the following criteria for termination is met adopted from British thoracic guidelines; respiratory rate 40/min or Spo2 90 despite max FiO2, worsening hypercapnia, deterioration of GCS 12, severe hemodynamic instability.
After HFNC application, Respiratory rate oxygenation index(ROX) AND HACOR score will be calculated at 1,2 and 6 hrs and will be compared to see which is better prognostic utility in predicting success of HFNC.Because NIV and HFNC both aim to prevent invasive ventilation, some studies have validated the HACOR scale for predicting HFNC failure, with most results showing favorable discrimination indices.
The primary outcome was HFNC success, defined as no intolerance or escalation towards mechanical ventilation or non-invasive ventilation within 48 h. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with acute hypoxemic respiratory failure (room air spo2 equal to less than 90% or PaO2 less than 60 mmhg).
The need for oxygen supplemental via face mask greater than 9 L/min to maintain spo2 greater than 92%. |
|
| ExclusionCriteria |
| Details |
Requiring immediate mechanical ventilation
Cardiopulmonary arrest
Pneumothorax
Severe respiratory acidosis or suspected hypercapnic respiratory failure.
Hemodynamic instability with MAP less than 65mmhg. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome was defined as no intolerance requiring hfnc removal and no escalation to invasive or non invasive ventilation within 48 hours after hfnc application i.e HFNC will be terminated if any of the following criteria for termination is met adopted from British thoracic guidelines; respiratory rate 40/min or Spo2 90 despite max FiO2, worsening hypercapnia, deterioration of GCS 12, severe hemodynamic instability. |
After applying HFNC, respiratory rate oxygenation (ROX) and HACOR(The HACOR score is based on five components: heart rate, acidosis, consciousness, oxygenation, and respiratory rate) score will be calculated at 1,2 and 6 hours after first application of HFNC. Patient will be observed for 48 hours to see if there is escalation of oxygenation support in the form of ventilator(invasive or non invasive) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare individual components of the scoring index |
Individual components of scoring (heart rate, respiratory rate & SpO2) will be assessed at 1,2 & 6 hours after application of HFNC. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/10/2024 |
| 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="1"
Months="6"
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
|
Oxygen delivered through HFNC has been successfully used in several settings. However the indications are not absolute with much of the prove and benefit being subject and physiologic most data to support it are derived from observational studies using physiological outcomes or from randomised trial studying heterogeneous population. As hfnc is non invasive and may benefit in overall mortality prevention in patients with respiratory failure, a proper scoring is lacking to predict the success of its application and preventing the escalation of therapy. The ROX index may help guidelines in this regard. The main aim of the study is to compare ROX index versus HACOR scale in predicting hfnc success in acute hypoxemic respiratory failure. At 1,2 and 6 hours after hfnc initiation two parameters will be assessed for the utility in predicting hfnc success. Hacor scale consists of five components with weighted score points the components are pulse rate (0-1), ph(0-4), GCS (0-10),PaO2/Fio2 (0-6) and respiratory rate(0-4).
|