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
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- SDM medical college and hospital
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- 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.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: At the end of 12 hours and 24 hours from baseline
Secondary Outcomes
- 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.)
Investigators
Dr Aditya Bhargav K
SDM college of medical sciences and hospital