| CTRI Number |
CTRI/2025/06/088044 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Outcomes Of High Flow Nasal Cannula In Covid Pneumonia |
|
Scientific Title of Study
|
Rox Index For Predicting
Outcomes Of High Flow Nasal Cannula In Covid Pneumonia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajesh Chandra |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology
2nd Floor, Hospital Building
RIMS, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9471300943 |
| Fax |
|
| Email |
chandrararjeshriims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Harish Kumar |
| Designation |
Critical Care Consultant |
| Affiliation |
Medanta Hospital |
| Address |
Department of Critical Care
Medanta Hopsital
National Highway 33, Irba, Ranchi - 835219 (Near United Bank Of India)
Ranchi
JHARKHAND
834009
India |
| Phone |
9471300943 |
| Fax |
|
| Email |
doctor.harish@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Chandra |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology
2nd Floor, Hospital Building
RIMS, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9471300943 |
| Fax |
|
| Email |
chandrarajeshriims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta Hospital Ranchi, P.O: Irba, P.S: Ormanjhi, NH33, Ranchi, Jharkhand 835217 |
|
|
Primary Sponsor
|
| Name |
Medanta Hospital |
| Address |
Medanta Hospital
Irba, Ranchi
Jharkhand-834009 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Rajesh Chandra |
Medanta Hospital |
Department of critical care
Medanta Hospital Ranchi, P.O: Irba, P.S: Ormanjhi, NH33, Ranchi, Jharkhand 835217
Ranchi
JHARKHAND |
9471300943
Chandrarajeshriims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are more than 18 yrs. old with hypoxemic respiratory
failure due to COVID-19 pneumonia |
|
| ExclusionCriteria |
| Details |
1. Patients younger than 18 years old, patients with indication for immediate
intubation.
2. Patients for whom HFNC will be used for extubation failures and those
with do-not-intubate order will be excluded.
3. Patients who will be electively intubated for diagnostic or therapeutic
procedures (bronchoscopy, surgery) will not be included. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the ROX index as a predictor of success of HFNC therapy for hypoxemic respiratory failure in COVID19 pneumonia |
SOFA (10) score will be recorded once a day during the first five days of HFNC therapy. We will also record the 4C COVID mortality score. (11) Clinical respiratory variables in patients 2h, 6h, 12h, 18h, and 24h after initiation of HFNC therapy will be recorded. After the first 24 hours, the same variables will be recorded once daily until HFNC withdrawal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the relation between ROX index & ICU stay, hospital stay, & outcomes of patients |
SOFA (10) score will be recorded once a day during the first five days of HFNC therapy. We will also record the 4C COVID mortality score. (11) Clinical respiratory variables in patients 2h, 6h, 12h, 18h, & 24h after initiation of HFNC therapy will be recorded. After the first 24 hours, the same variables will be recorded once daily until HFNC withdrawal |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/06/2025 |
| 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="1"
Months="1"
Days="1" |
|
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 - NO
|
|
Brief Summary
|
In patients with COVID-19 pneumonia treated for acute hypoxemic respiratory failure, there has been an increase in the utilization of non-invasive ventilation and high-flow nasal cannula (HFNC). Its increased use can be attributed to ease of use, ability to achieve higher FiO2, need for lesser expertise, use in extubation failure, and feasibility to use even in tracheostomized patients. This is especially true in countries that require more resources.1 It was also established that the risk of aerosol formation was decreased with a high-flow nasal cannula, which supports its use in COVID-19 pneumonia.2 We would like to conduct a prospective observational study to validate the ROX index as a method for predicting the failure of HFNC therapy in COVID-19 pneumonia. |