| CTRI Number |
CTRI/2026/04/109341 [Registered on: 24/04/2026] Trial Registered Prospectively |
| Last Modified On: |
15/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of High-Flow Nasal Oxygen and Non-Invasive Ventilation in Patients with Acute COPD Exacerbations and Type II Respiratory Failure |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF EFFECTS OF HIGH
FLOW NASAL OXYGEN THERAPY AND NON-
INVASIVE VENTILATION IN PATIENTS WITH ACUTE
EXACERBATION OF COPD IN COMBINATION WITH
TYPE TWO 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 |
DR SANJAY KUMAR GUPTA |
| Designation |
Head Of Department |
| Affiliation |
Hindu Rao Hospital Delhi |
| Address |
HOD Office Department of Anesthesia Hindu Rao Hospital Delhi
North
DELHI
110007
India |
| Phone |
9810655949 |
| Fax |
|
| Email |
hodanesthesiahrh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY KUMAR GUPTA |
| Designation |
Head Of Department |
| Affiliation |
Hindu Rao Hospital Delhi |
| Address |
HOD Office Department of Anesthesia Hindu Rao Hospital Delhi
North
DELHI
110007
India |
| Phone |
9810655949 |
| Fax |
|
| Email |
hodanesthesiahrh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANJAY KUMAR GUPTA |
| Designation |
Head Of Department |
| Affiliation |
Hindu Rao Hospital Delhi |
| Address |
HOD Office Department of Anesthesia Hindu Rao Hospital Delhi
North
DELHI
110007
India |
| Phone |
9810655949 |
| Fax |
|
| Email |
hodanesthesiahrh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hindu Rao Hospital, Malka Ganj Delhi 110007 |
|
|
Primary Sponsor
|
| Name |
Hindu Rao Hospital |
| Address |
Gandhi Square, Malka Ganj Delhi 110007 |
| 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 |
| Dr Mohd RAFEY KHAN |
Hindu Rao Hospital, Subzi Mandi, Malkaganj, Delhi- 110007 |
Intensive Care Unit, Hindu Rao Hospital, Subzi Mandi, Malkaganj, Delhi- 110007
North
DELHI |
8377085674
dr.mrafeyk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BiPAP/NIV |
A BiPAP (Bilevel Positive Airway Pressure) machine is a noninvasive ventilator used to assist breathing by delivering pressurized air through a mask. It provides two distinct pressure levels: higher pressure when inhaling (IPAP) and lower pressure when exhaling (EPAP)
Total duration of BiPAP/NIV would be 24 hrs from enrollment. |
| Intervention |
HIGH FLOW NASAL OXYGENAION |
High-flow nasal oxygenation (HFNO) or high-flow nasal cannula (HFNC) is a noninvasive respiratory support system that delivers heated, fully humidified, and blended oxygen at high flow rates (up to 60–80 L/min). It surpasses a patient’s inspiratory demand, offering precise oxygen concentrations (21%–100%) and mild positive airway pressure
Total duration of intervention would be 24 hrs from enrollment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed mild to moderate AECOPD with Type 2 respiratory failure
Patient or legally authorized representative providing informed consent |
|
| ExclusionCriteria |
| Details |
ANY NEED FOR URGENT INTUBATION
PH LESS THAN 7.2
Severe hypoxia pO2 LESS THAN 50
Respiratory rate LESS THAN 8 or MORE THAN 40
Inability to protect airways
Respiratory or cardiac arrest
Requirement for urgent intubation
Factors such as suspected drug overdose, end-stage cancer, cerebrovascular accident, recent myocardial infarction, hemodynamic instability,
HISTORY OF Pulmonary Kochs
Ischemic Heart Disease
Arrythmias
Pericarditis
Pulmonary edema
Pleural effusion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the decrease in PaCO2 levels in the patients of AECOPD with T2RF with HFNO in comparison to NIV. |
AT ICU admission (T1)
o 2 HRS after intervention (T2)
o 6 HRS after intervention (T3)
o 12 HRS after intervention (T4)
o 18 HRS after intervention (T5)
o 24 HRS after intervention (T6) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare change in pao2 levels with HFNO & NIV
To compare patient comfort with HFNO & NIV
To compare treatment failure rates between the two groups |
AT ICU admission (T1)
o 2 HRS after intervention (T2)
o 6 HRS after intervention (T3)
o 12 HRS after intervention (T4)
o 18 HRS after intervention (T5)
o 24 HRS after intervention (T6) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/04/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This study is a prospective randomized interventional trial aimed at comparing the effectiveness of High-Flow Nasal Oxygen (HFNO) and Non-Invasive Ventilation (NIV) in patients with acute exacerbation of COPD (AECOPD) with Type II respiratory failure. COPD is a major global health problem, and while NIV is the current standard treatment, it has limitations such as poor tolerance and significant failure rates. HFNO has emerged as a promising alternative due to better patient comfort, improved oxygen delivery, and reduction in work of breathing.
The primary objective is to compare the reduction in PaCO2 levels between HFNO and NIV. Secondary objectives include comparison of PaO2 improvement, patient comfort, and treatment failure rates.
A total of 100 patients (18–70 years) meeting inclusion criteria will be enrolled and randomly allocated into two groups: HFNO (50 patients) and NIV (50 patients). Clinical parameters, arterial blood gases, and indices like the ROX index will be monitored at predefined intervals over 24 hours or until treatment failure.
Data will be analyzed using appropriate statistical methods (SPSS), with significance set at p less than 0.05.
The study aims to determine whether HFNO can be a better or comparable alternative to NIV in managing hypercapnic respiratory failure in COPD exacerbations, potentially improving patient outcomes and comfort. |