Breath-actuated Nebulizers in Acute COPD Exacerbations

Status unconfirmed · Not applicable

Conditions studied: COPD Exacerbation

In brief

The goal of this study is to evaluate the utilization and outcomes of AeroEclipse® II Breath Actuated Nebulizer (BAN, Monaghan Medical Corporation, Plattsburgh, NY) vs. standard continuous flow nebulizers (SN). We hypothesize that the use of AeroEclipse® II BAN will reduce the number of nebulizer treatments needed (primary outcome).

Key facts

Study ID

NCT03985748

Run by

Rhode Island Hospital

People needed

150

Starts

2019-10-01

Expected to finish

2021-07-01

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be 18 years or older and must be admitted to RIH for acute COPD exacerbation
• Patient must be able to understand the information about the research protocol that is provided by the investigators and be able to sign the informed consent form.
• If a patient does not meet this criterion, consent can be obtained from a surrogate decision maker
• Spanish speaking patients will be included and consent will be obtained using the short form and an interpreter. The SGRQ-C is translated and validated in Spanish and is readily available.

You may not qualify if…

• Patients who are unable or unwilling to receive nebulizer treatments per assigned randomization group
• Inability to enroll patient within 24 hours of presentation to the Emergency Department, where Time 0 = triage time, or before administration of the 5th nebulizer treatment, whichever comes first
• Pregnant women
• Prisoners
• Anyone who uses a BAN as an outpatient
• Patients on continuous BiPAP
• ** These patients usually get nebs administered via an in-line nebulizer device that goes directly into the BiPAP tubing. For those receiving continuous BiPAP, the hand-held BAN cannot be used, as it does not offer an in-line option. In contrast, for those on intermittent BiPAP, patients usually receive hand-held nebulizer, thus remain eligible for BAN, as long as they have the capacity to use the hand-held nebulizer
• Patients who are intubated (orotracheal or nasotracheal) or have a tracheostomy tube *** The hand-held BAN cannot be used for the same reason as for patients on BiPAP

Where it is running

• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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