Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation During Respiratory Failure in Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- National University Health System, Singapore
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Difference in mean end-expiratory lung volumes between the two nebulization methods.
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
The study aim to evaluate effectiveness of two bronchodilator nebulization strategies in patients with acute decompensated type 2 respiratory failure due to acute exacerbation of chronic obstructive pulmonary disease..
Detailed Description
Decompensated type 2 respiratory failure during acute exacerbation of chronic obstructive pulmonary disease (COPD) is treated with non-invasive ventilation (NIV) and nebulized bronchodilators. Nebulization during NIV can be applied by two methods: in-line nebulization through NIV mask and off-NIV nebulization during which NIV mask is taken off for a short time and reapplied when nebulization is finished. This study is a prospective randomized controlled trial to compare in-line nebulization through NIV versus off- NIV nebulization. After starting NIV in eligible COPD patients with type 2 respiratory failure, the baseline end-expiratory lung impedance (EELI) will be measured. Patient is randomized to receive either in-line or off-NIV nebulization. EELI will be measured again following completion of the nebulization, 15min after NIV is restarted (off-NIV group) or continued (in-line group). Ultrasound measurement of the thickness of the diaphragm will be recorded at baseline, 15min after NIV is restarted (off-NIV group) or continued (in-line group) and 48 hours after stopping the NIV. The main outcome measure, difference in mean end expiratory lung volume at 15min after NIV is restarted (off-NIV group) or continued (in-line group) between the two nebulization methods will be compared using independent sample T test. Thickness of the diaphragm and changes in the arterial blood gases (in terms of pH and carbon-di-oxide) will be compared between in-line nebulization and off-NIV nebulization.
Investigators
Amartya Mukhopadhyay
Principal investigator
National University Health System, Singapore
Eligibility Criteria
Inclusion Criteria
- •Age ≥21 years.
- •Known or suspected COPD (defined by a ratio of Forced Expiratory Volume in 1 second (FEV1) to Forced Vital Capacity (FVC) of less than 0.7).
- •Acute decompensated type 2 respiratory failure (ABG pH ≤ 7.35 and PaCO2\>45mmHg).
- •Clinical decision made to start NIV.
Exclusion Criteria
- •Other acute decompensated type 2 respiratory failure related conditions (e.g. neuromuscular, heart failure etc.).
- •Pneumonia present in the chest radiograph.
- •Other conditions which may change lung impedance (e.g. heart failure or lung fibrosis).
Outcomes
Primary Outcomes
Difference in mean end-expiratory lung volumes between the two nebulization methods.
Time Frame: At baseline (approximately 15min after starting NIV) to approximately 15min after restarting (or continuing NIV) following the nebulization.
End-expiratory lung volumes between in-line nebulization and off-NIV nebulization.
Secondary Outcomes
- Thickness of the diaphragm (by ultrasound) between in-line nebulization and off-NIV nebulization.(At baseline (approximately 15min after starting NIV) to approximately 15min after restarting (or continuing NIV) following the nebulization and repeated 48hours after stopping NIV.)
- Changes in arterial blood gases in terms of pH and carbon dioxide between in-line. nebulization and off-NIV nebulization.(At baseline (approximately 15min after starting NIV) to approximately 15min after restarting (or continuing NIV) following the nebulization.)