| CTRI Number |
CTRI/2025/07/090913 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between high flow nasal cannula therapy and non invasive ventilation in treating acute exacerbation of chronic obstructive pulmonary disease with type 2 respiratory failure |
|
Scientific Title of Study
|
High flow nasal cannula therapy (HFNC) vs Non-Invasive Ventilation (NIV) in acute hypercapnic chronic obstructive pulmonary disease (COPD)
exacerbation- a non inferiority randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditya Bhargav K |
| Designation |
Postgraduate resident |
| Affiliation |
SDM college of medical sciences and hospital |
| Address |
Room no 12, respiratory medicine department, SDM college of medical sciences and hospital, Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
8553546856 |
| Fax |
|
| Email |
spoxcy001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay S |
| Designation |
Professor and Head of Department |
| Affiliation |
SDM college of medical sciences and hospital |
| Address |
Room no 12, Respiratory medicine department, SDM college of medical sciences and hospital, Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
9380378825 |
| Fax |
|
| Email |
ssanjay1361985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya Bhargav K |
| Designation |
Postgraduate resident |
| Affiliation |
SDM college of medical sciences and hospital |
| Address |
Room no 12, Respiratory medicine department, SDM college of medical sciences and hospital, Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
8553546856 |
| Fax |
|
| Email |
spoxcy001@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical sciences and hospital, Manjushree nagar, Sattur, Dharwad, Karnataka, India 580009 |
|
|
Primary Sponsor
|
| Name |
SDM medical college and hospital |
| Address |
SDM college of medical sciences and hospital, Manjushree nagar, stature, Dharwad 580009 |
| Type of Sponsor |
Private 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 |
| Dr Aditya Bhargav |
SDM college of medical sciences and hospital |
SDM college of medical sciences and hospital, manjushree nagar, sattur, Dharwad 580009
Dharwad
KARNATAKA |
8553546856
spoxcy001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Medical Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High flow nasal cannula |
High flow nasal cannula therapy to treat acute exacerbation of COPD with type 2 respiratory failure |
| Comparator Agent |
Non- invasive ventilation |
Non-invasive ventilation in treating acute exacerbation of COPD with type 2 respiratory failure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults diagnosed with COPD exacerbation according to GOLD criteria.
Arterial pH between 7.25 to 7.35 at time of presentation (mild to moderate exacerbation)
Arterial PaCO2 more than 45mmHg at time of presentation.
|
|
| ExclusionCriteria |
| Details |
Patient who are on long term domiciliary NIV therapy.
Clinical cardiovascular instability.
Acute failure of more than equal to two organs.
Need for immediate intubation or cardiorespiratory arrest.
Facial / neck trauma or deformity
Consent withdrawal.
Treatment refusal.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate whether HFNC therapy is non-inferior to NIV in reducing arterial pCO2 and pH after 12 and 24 hours of treatment in patients with acute exacerbation of COPD. |
At the end of 12 hours and 24 hours from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in respiratory rate, dyspnea score using Modified Borg scale, and treatment change rates at 12 and 24 hours of treatment. |
At the end of 12 hours and 24 hours from baseline. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a randomized controlled non-inferiority trial comparing High Flow Nasal Cannula (HFNC) therapy with Non-Invasive Ventilation (NIV) in patients experiencing acute hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD). Given the high burden of COPD in India and limitations associated with NIV such as discomfort, poor tolerance, and failure in up to 30% of cases, the study aims to evaluate whether HFNC, which offers better patient comfort and similar efficacy in managing respiratory acidosis, can be a non-inferior alternative. The primary objective is to assess changes in arterial pCO2 and pH after 12 and 24 hours of treatment, while secondary objectives include changes in respiratory rate, dyspnea score, and treatment modifications. The findings are expected to support HFNC as an effective and more tolerable therapeutic option for managing acute hypercapnic COPD exacerbations in clinical practice.
|