An interventional study of In-line nebulization through NIV mask and Off-NIV nebulization in Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Respiratory Failure, sponsored by National University Health System, Singapore. Terminated at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by National University Health System, Singapore · Not applicable, Interventional, and Treatment
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..
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 11 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
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Exclusion Criteria:
Bronchodilator nebulization is given through NIV circuit.
Procedure: In-line nebulization through NIV mask
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
In-line nebulization will be given through NIV circuit.
Bronchodilator nebulization is given during which NIV mask is taken off for a short time and reapplied when nebulization is finished..
Difference in mean end-expiratory lung volumes between the two nebulization methods.
End-expiratory lung volumes between in-line nebulization and off-NIV nebulization.
Time frame: At baseline (approximately 15min after starting NIV) to approximately 15min after restarting (or continuing NIV) following the nebulization.
Thickness of the diaphragm (by ultrasound) between in-line nebulization and off-NIV nebulization.
Measure thickness of the diaphragm between inspiration and expiration.
Time frame: 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.
Time frame: At baseline (approximately 15min after starting NIV) to approximately 15min after restarting (or continuing NIV) following the nebulization.
Plan to share: No
Ran from Apr 2018 to primary completion in Nov 2020, 31 months.
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This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
National University Health System, Singapore