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Breath-actuated Nebulizers in Acute COPD Exacerbations

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ClinicalTrials.gov Identifier: NCT03985748
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Monaghan Medical Corporation
Information provided by (Responsible Party):
Rhode Island Hospital

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).

Condition or disease Intervention/treatment Phase
COPD Exacerbation Device: BAN Device: SN Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Utilization and Effectiveness of Breath-actuated Nebulizers in Acute COPD Exacerbations
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Breath Actuated Nebulizers (BAN)
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
Inhaled bronchodilators will be delivered using an AeroEclipse® II Breath Actuated Nebuliz (BAN)

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




Primary Outcome Measures :
  1. Total number of nebulizer treatments administered [ Time Frame: Through study completion, an average of 6 months ]
    Medication administration data gathered from electronic medical record (EMR) after patient discharge

  2. Time to nebulizer treatment de-escalation (i.e. standing order to prn order to discontinuation) [ Time Frame: Through study completion, an average of 6 months ]
    Medication administration data gathered from EMR after patient discharge to determine when standing nebulizer orders are changed to as needed (prn) nebulizer orders

  3. Time to return to baseline supplemental oxygen requirement [ Time Frame: Through study completion, an average of 6 months ]
    Supplemental oxygen data gathered from respiratory/nursing flow sheets. For patients not on supplemental oxygen at baseline, time to return to room air


Secondary Outcome Measures :
  1. Hospital length of stay (LOS) [ Time Frame: Through study completion, an average of 6 months ]
    Gathered from the EMR hospital course

  2. Need for transfer to a higher level of care and LOS on those units [ Time Frame: Through study completion, an average of 6 months ]
    Gathered from EMR

  3. Progression to intubation/mechanical ventilation [ Time Frame: Through study completion, an average of 6 months ]
    Gathered from EMR

  4. Time requiring non-invasive positive pressure ventilation [ Time Frame: Through study completion, an average of 6 months ]
    Device duration data gathered from EMR Respiratory complications

  5. Discharge location [ Time Frame: Through study completion, an average of 6 months ]
    Where the patient was discharged to after hospitalization (i.e. home, skilled nursing facility, inpatient rehab)

  6. Hospital Mortality [ Time Frame: Through study completion, an average of 6 months ]
    EMR death record

  7. 6-month post-discharge data [ Time Frame: Through study completion, an average of 6 months ]
    Access medical records of those that are enrolled for up to 6 months post discharge. This will allow us to obtain PFT reports for patients that did not have PFTs pre-hospitalization and to determine many times subjects are re admitted in 6 months (another secondary outcome)

  8. 30-day (+ 7 days) readmission rate [ Time Frame: Through study completion, an average of 6 months ]
    EMR review and/or patient phone contact

  9. Patient-reported ease of device use (USE Questionnaire) [ Time Frame: Through study completion, an average of 6 months ]
    5-10 minutes to complete, completed on study Day 3 (± 1 day)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985748


Contacts
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Contact: Jason M Aliotta, MD 401-444-0008 jason_aliotta@brown.edu

Sponsors and Collaborators
Rhode Island Hospital
Monaghan Medical Corporation

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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03985748     History of Changes
Other Study ID Numbers: 1204420-9
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Rhode Island Hospital:
Nebulizer
Breath Actuated Nebulizer

Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases