Comparing two non-invasive ventilation methods for COPD exacerbations

Randomised Control Trial to Study the Role of Non-invasive Ventilation Using Pressure Support Ventilation Versus Adaptive Support Ventilation With Intellisync Mode in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

This study is testing which non-invasive breathing support method, pressure support ventilation or adaptive support ventilation, works better for people with COPD who are having a serious flare-up.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 13 Years and up
• Sex: All
• Sponsor: PGIMER (unknown)
• Locations: 1 site (Chandigarh)
• Trial ID: NCT06160687 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of pressure support ventilation (PSV) versus adaptive support ventilation (ASV) with Intellisync mode in delivering non-invasive ventilation (NIV) to patients experiencing acute exacerbations of chronic obstructive pulmonary disease (COPD). The research focuses on patients who have a significant worsening of respiratory symptoms and aims to determine which ventilation method provides better outcomes in terms of respiratory function and overall survival. By analyzing arterial blood gas levels and patient responses, the study seeks to optimize NIV therapy for those affected by COPD exacerbations.

Who should consider this trial

Good fit: Ideal candidates for this study are patients experiencing an acute exacerbation of COPD with specific respiratory symptoms and blood gas abnormalities.

Not a fit: Patients with non-COPD related respiratory failure or severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve survival rates and quality of life for patients suffering from acute COPD exacerbations.

How similar studies have performed: Previous studies have shown that non-invasive ventilation can significantly reduce mortality in COPD exacerbations, suggesting that this approach has a foundation of success.

Eligibility criteria

Inclusion Criteria:

Consecutive subjects with AECOPD will be eligible for inclusion in the study if they meet all the following:

1. an acute (\<7 days) sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity or character, dyspnea) beyond the normal day-to-day variation;
2. arterial blood gas analysis showing a PaCO2 \>45 mm Hg with either pH between 7.25 and 7.35 or respiratory rate (18) \>30 breaths/minute; and,
3. exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.

Exclusion Criteria:

Patients with any one of the following criteria will be excluded from the current study:

1. Non-COPD acute hyper-capneic respiratory failure.
2. Hypotension (systolic blood pressure \<90 mmHg).
3. Severe impairment of consciousness (Glasgow coma scale score \<8).
4. Inability to clear respiratory secretions.
5. Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality).
6. Subjects who have an artificial airway like tracheostomy tube or T-tube.
7. Patient already on home NIV therapy for chronic respiratory failure.
8. Failure to provide informed consent.

Where this trial is running

Chandigarh

• Respiratory ICU, Department of Pulmonary Medicine, PGIMER — Chandigarh, India (RECRUITING)

Conditions: COPD Exacerbation Acute, COPD Exacerbation