Clinical trial NCT03481543: Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation in COPD
Official title: Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation During Respiratory Failure in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Type 2 Respiratory Failure
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Nebulization
Respiratory failure
Non-invasive ventilation(NIV)
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Difference in mean end-expiratory lung volumes between the two nebulization methods.
timeFrame: At baseline (approximately 15min after starting NIV) to approximately 15min after restarting (or continuing NIV) following the nebulization.
Secondary outcomes:
measure: Thickness of the diaphragm (by ultrasound) between in-line nebulization and off-NIV nebulization.
timeFrame: 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: Changes in arterial blood gases in terms of pH and carbon dioxide between in-line. nebulization and off-NIV nebulization.
timeFrame: At baseline (approximately 15min after starting NIV) to approximately 15min after restarting (or continuing NIV) following the nebulization.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Health System
name: Amartya Mukhopadhyay, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brochard L, Mancebo J, Wysocki M, Lofaso F, Conti G, Rauss A, Simonneau G, Benito S, Gasparetto A, Lemaire F, et al. Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1995 Sep 28;333(13):817-22. doi: 10.1056/NEJM199509283331301.
citation: Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.
citation: Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001 Apr;163(5):1256-76. doi: 10.1164/ajrccm.163.5.2101039. No abstract available.