NCT03481543

Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation in COPD

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: National University Health System, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• Type 2 Respiratory Failure

Interventions

Type	Name	Description
PROCEDURE	In-line nebulization through NIV mask	In-line nebulization will be given through NIV circuit.
PROCEDURE	Off-NIV nebulization	Bronchodilator nebulization is given during which NIV mask is taken off for a short time and reapplied when nebulization is finished..

Timeline

• Start date: 2018-04-10
• Primary completion: 2020-11-12
• Completion: 2020-11-12
• First posted: 2018-03-29
• Last updated: 2022-10-13

Locations

1 site across 1 country: Singapore