Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation in COPD

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Type 2 Respiratory Failure
• Interventions: Procedure: In-line nebulization through NIV mask; Procedure: Off-NIV nebulization

• Registration Number: NCT03481543
• Lead Sponsor: National University Health System, Singapore

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.

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-03-29
• Study Start: 2018-04-10
• Primary Completion: 2020-11-12
• Study Completion: 2020-11-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. Age ≥21 years.
2. 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).
3. Acute decompensated type 2 respiratory failure (ABG pH ≤ 7.35 and PaCO2>45mmHg).
4. Clinical decision made to start NIV.

Exclusion Criteria

1. Other acute decompensated type 2 respiratory failure related conditions (e.g. neuromuscular, heart failure etc.).
2. Pneumonia present in the chest radiograph.
3. Other conditions which may change lung impedance (e.g. heart failure or lung fibrosis).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-line nebulization through NIV mask	In-line nebulization through NIV mask	Bronchodilator nebulization is given through NIV circuit.
Off-NIV nebulization	Off-NIV nebulization	Bronchodilator nebulization is given during which NIV mask is taken off for a short time and reapplied when nebulization is finished.

Primary Outcome Measures

Name	Time	Method
Difference in mean end-expiratory lung volumes between the two nebulization methods.	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 Outcome Measures

Name	Time	Method
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.	Measure thickness of the diaphragm between inspiration and expiration.
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.	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.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore