Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation in COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation During Respiratory Failure in Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease (COPD), Type 2 Respiratory Failure

Intervention / Treatment
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* Procedure: In-line nebulization through NIV mask
* Procedure: Off-NIV nebulization


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-line nebulization through NIV mask<br>Bronchodilator nebulization is given through NIV circuit. | Procedure: In-line nebulization through NIV mask<br>* In-line nebulization will be given through NIV circuit.<br>|
| Active Comparator: Off-NIV nebulization<br>Bronchodilator nebulization is given during which NIV mask is taken off for a short time and reapplied when nebulization is finished. | Procedure: Off-NIV nebulization<br>* Bronchodilator nebulization is given during which NIV mask is taken off for a short time and reapplied when nebulization is finished..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean end-expiratory lung volumes between the two nebulization methods. | End-expiratory lung volumes 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of the diaphragm (by ultrasound) between in-line nebulization and off-NIV nebulization. | Measure thickness of the diaphragm between inspiration and expiration. | 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. | Measure changes of arterial blood gases between in-line nebulization and off-NIV. nebulization. Differences in pH (absolute,no unit) and carbon dioxide (in mmHg) will be noted. | At baseline (approximately 15min after starting NIV) to approximately 15min after restarting (or continuing NIV) following the nebulization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease (COPD), Nebulization, Respiratory failure, Non-invasive ventilation(NIV)