Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation in COPD

NCT03481543 | Terminated

• 1 other identifier: DSRB 2017/00990
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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..

Conditions

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

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Nebulization; Respiratory failure; Non-invasive ventilation(NIV)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (2)

In-line nebulization through NIV mask

EXPERIMENTAL

Bronchodilator nebulization is given through NIV circuit.

Procedure: In-line nebulization through NIV mask

Off-NIV nebulization

ACTIVE COMPARATOR

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

Interventions

In-line nebulization through NIV mask PROCEDURE

In-line nebulization will be given through NIV circuit.

In-line nebulization through NIV mask

Off-NIV nebulization PROCEDURE

Bronchodilator nebulization is given during which NIV mask is taken off for a short time and reapplied when nebulization is finished..

Off-NIV nebulization

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National University Health System, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (3)

• 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.

  PMID: 7651472 RESULT

• 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.

  PMID: 22476448 RESULT

• 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.

  PMID: 11316667 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoventilation; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Amartya Mukhopadhyay, MBBS

  National University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 29, 2018
• Study Start: April 10, 2018
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)