| CTRI Number |
CTRI/2025/03/081783 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE THE EFFICACY OF HFNC VS NIV IN ACUTE EXACERBATION OF COPD |
|
Scientific Title of Study
|
COMPARATIVE EFFICACY OF HIGH FLOW NASAL CANNULA VERSUS NON-INVASIVE VENTILATION IN PATIENTS WITH ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE: A RANDOMIZED CONTROLLED TRIAL |
| 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 AASTHA TIWARI |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
DEPARTMENT OF EMERGENCY MEDICINE
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
NEW DELHI
South West
DELHI
110029
India |
| Phone |
8826216416 |
| Fax |
|
| Email |
ttiwari.1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MEERA EKKA |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS NEW DELHI |
| Address |
DEPARTMENT OF EMERGENCY MEDICINE
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
NEW DELHI
South West
DELHI
110029
India |
| Phone |
9811298656 |
| Fax |
|
| Email |
drmeera_2004@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR MEERA EKKA |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS NEW DELHI |
| Address |
DEPARTMENT OF EMERGENCY MEDICINE
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
NEW DELHI
South West
DELHI
110029
India |
| Phone |
9811298656 |
| Fax |
|
| Email |
drmeera_2004@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES,ANSARI NAGAR,SOUTH WEST DELHI, DELHI -110029 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF EMERGENCY MEDICINE |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| 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 AASTHA TIWARI |
EMERGENCY ROOM EM1 EM3 |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR NEW DELHI
South West
DELHI |
8826216416
ttiwari.1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INIDA INSTITUTE OF MEDICAL SCIENCES , ANSARI NAGAR, NEW DELHI 110029 |
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 |
HEATED HUMIDIFIED HIGH FLOW NASAL CANNULA |
HHHFNC WILL BE STARTED FOR PATIENTS OF AECOPD WHO WILL BE RANDOMIZED TO INTERVENTION ARM AFTER RECEIVING STANDARD MEDICAL TREATMENT AND NOT BENEFITTING FROM IT.IT WILL BE CONTINUED TILL RESOLUTION OF ACIDOSIS IN BLOOD GAS. |
| Comparator Agent |
NON-INVASIVE VENTILATION |
NON-INVASIVE VENTILATION WILL BE STARTEED FOR PATIENTS OF AECOPD WHO WILL BE RANDOMIZED TO CONTROL ARM AFTER RECEIVING STANDARD MEDICAL TREATMENT AND NOT BENEFITTING FROM IT . IT WILL BE CONTINUED TILL THE RESOLUTION OF ACIDOSIS. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH AGE MORE THAN OR EQUAL TO 18 YEARS WITH AECOPD |
|
| ExclusionCriteria |
| Details |
Patients who have already received HFNC or NIV prior to enrollment in study
Patients who are on long term domiciliary NIV support
Patients who are in need of vasopressor support
Patients with acute coronary syndrome or life-threatening arrhythmias
Unconscious or uncooperative patients
Patients who are in cardiorespiratory arrest and those who require mechanical ventilation
Patients who suffered recent trauma to neck or face
Pregnant females
Patients who are on treatment with palliative intent
Patients having active hemoptysis or active upper gastrointestinal bleeding
Patients having pneumothorax, neuromuscular weakness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rate of change in values of arterial partial pressure of carbon dioxide (Pco2) and pH from baseline arterial blood gas values in patients with acute exacerbation of chronic obstructive pulmonary disease treated with high flow nasal cannula versus non-invasive ventilation at 2 hours from enrollment in study |
At 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the rate of change in values of arterial partial pressure of carbon dioxide (Pco2) & pH from baseline arterial blood gas values in patients with acute exacerbation of chronic obstructive pulmonary disease treated with high flow nasal cannula versus non-invasive ventilation at 6 hours from start of treatment
To compare treatment failure rates between HFNC & NIV group
To compare the rate of need for treatment switch between HFNC & NIV group
To compare the rate of invasive mechanical ventilation needed in HFNC & NIV group
To compare emergency department & hospital length of stay in HFNC & NIV group
To compare in hospital mortality & mortality within 30 days of enrollment in study between HFNC & NIV group |
At 6 hours from enrollment in study
At 30 days from enrollment in study |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
01/04/2025 |
| 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
|
It is a prospective open label randomized controlled trial of parallel group to compare the efficacy of high flow nasal cannula oxygen therapy versus non-invasive ventilation in patients diagnosed with acute exacerbation of chronic obstructive pulmonary disease. After providing standard medical treatment (in the form of bronchodilators , oxygen , steroids and antibiotics) to the patients of AECOPD , those who do not improve with it will be randomized using computer generated randomisation sequence and allocation concealment will be through SNOSE technique. All patients who will be recruited in the study will be explained about the study , given a patient information sheet and they will sign a consent form provided both in hindi and english. Our primary objective of doing the study is to compare rate of pH and PaCO2 change from baseline to 2 hours between both HFNC and NIV group . Secondary objectives include comparing rate of pH and PaCO2 change from baseline to 6 hours between both HFNC and NIV group , comparing rate of treatment failure in both groups , rate of treatment switch in both groups , need for mechanical ventilation in both groups, length of emergency department and hospital stay in both groups and mortality within hospital and from 30 days of enrollment between both groups. |