Breath-actuated Nebulizers in Acute COPD Exacerbations

NCT03985748 | Unknown FDA Device

• 1 other identifier: 1204420-9
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

COPD Exacerbation

Keywords

Nebulizer; Breath Actuated Nebulizer

Outcome Measures

Primary Outcomes (3)

• Total number of nebulizer treatments administered

  Medication administration data gathered from electronic medical record (EMR) after patient discharge

  Through study completion, an average of 6 months

• Time to nebulizer treatment de-escalation (i.e. standing order to prn order to discontinuation)

  Medication administration data gathered from EMR after patient discharge to determine when standing nebulizer orders are changed to as needed (prn) nebulizer orders

  Through study completion, an average of 6 months

• Time to return to baseline supplemental oxygen requirement

  Supplemental oxygen data gathered from respiratory/nursing flow sheets. For patients not on supplemental oxygen at baseline, time to return to room air

  Through study completion, an average of 6 months

Secondary Outcomes (9)

• Hospital length of stay (LOS)

  Through study completion, an average of 6 months

• Need for transfer to a higher level of care and LOS on those units

  Through study completion, an average of 6 months

• Progression to intubation/mechanical ventilation

  Through study completion, an average of 6 months

• Time requiring non-invasive positive pressure ventilation

  Through study completion, an average of 6 months

• Discharge location

  Through study completion, an average of 6 months

Study Arms (2)

Breath Actuated Nebulizers (BAN)

EXPERIMENTAL

Enrolled patients will be randomized to receive AeroEclipse® II BAN or SN in the RIH Emergency Department. They will have an equal chance of being placed in either group. Patients will be screened and identified in the Emergency Department. They will receive the BAN or SN for the duration of their stay in the hospital, as long as clinically indicated.

Device: BAN

Standard Nebulizer (SN)

ACTIVE COMPARATOR

Enrolled patients will be randomized to receive AeroEclipse® II BAN or SN in the RIH Emergency Department. They will have an equal chance of being placed in either group. Patients will be screened and identified in the Emergency Department. They will receive the BAN or SN for the duration of their stay in the hospital, as long as clinically indicated.

Device: SN

Interventions

BAN DEVICE

Inhaled bronchodilators will be delivered using an AeroEclipse® II Breath Actuated Nebuliz (BAN)

Breath Actuated Nebulizers (BAN)

SN DEVICE

Inhaled bronchodilators will be delivered using a Standard Nebulizer (SN)

Standard Nebulizer (SN)

Eligibility Criteria

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

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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Monaghan Medical Corporation: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled patients will be randomized to receive AeroEclipse® II BAN or SN in the Rhode Island Hospital (RIH) Emergency Department. They will have an equal chance of being placed in either group. Patients will be screened and identified in the Emergency Department. They will receive the BAN or SN for the duration of their stay in the hospital, as long as clinically indicated.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 14, 2019
• Study Start: October 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-09

Locations

US (1)