| CTRI Number |
CTRI/2025/09/094735 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of high flow nasal oxygenation in non covid mild to moderate acute respiratory distress syndrome |
|
Scientific Title of Study
|
Efficacy of high flow nasal oxygenation in non covid mild to moderate acute respiratory distress syndrome : 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 PRIYA RATHORE |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anaesthesiology King Georges Medical University lucknow 226003 (UP) India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8808420153 |
| Fax |
|
| Email |
dr.gritty0333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. B B Kushwaha |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anaesthesiology King Georges Medical University lucknow 226003 (UP) India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9336900634 |
| Fax |
|
| Email |
brij_kushwaha00634@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRIYA RATHORE |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anaesthesiology King Georges Medical University lucknow 226003 (UP) India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8808420153 |
| Fax |
|
| Email |
dr.gritty0333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology King Georges Medical University lucknow 226003 (UP) India |
|
|
Primary Sponsor
|
| Name |
Dr Priya Rathore |
| Address |
Department of Anaesthesiology King Georges Medical University lucknow 226003 (UP) India |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Priya Rathore |
King Georges Medical University |
Department of Anaesthesia, King Georges Medical University, Lucknow. India
Lucknow
UTTAR PRADESH |
9188084 20153
dr.gritty0333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult 18-60years patient of either sex with ARDS with New Global Definition of ARDS
1 Acute onset within one week
2 Bilateral chest infiltrates in x ray or CT or Bilateral B lines and or consolidation in ultrasound
3 SpO2/FiO2 less than 315
4 PaO2/FiO2 less than 300
5 No evidence of left heart failure or fluid overload
|
|
| ExclusionCriteria |
| Details |
1 Severe ARDS PaO2/FiO2 less than 100 or SpO2/FiO2 less than 148
2 Covid positive patients.
3 Pregnant Female
4 Neurological condition, cardiac failure, structural heart disease
5 Any other co-existing lung pathology
6 Any contraindication for nasal canula (nasal obstruction, recent nasal surgery)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Requirement of Mechanical Ventilation |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Discharge without mechanical ventilation event |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
26/09/2025 |
| 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="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
|
in order to assess the effectiveness of HFNO in recovery of typical mild to moderate ARDS (non-covid) and lowering the requirement for invasive mechanical ventilation, we designed a prospective study on ICU admitted non-covid mild to moderate ARDS patients. |