- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03051971
Medicated Aerosol Delivery Using A Jet Nebulizer Versus A Vibrating Mesh Nebulizer in COPD Exacerbation
A Pilot Study of Medicated Aerosol Delivery Using A Jet Nebulizer Versus A Vibrating Mesh Nebulizer in COPD Exacerbation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients ordered to receive a SABD, will be screened for presence of moderate to severe COPD exacerbation; spontaneously breathing patients as well those supported with non-invasive ventilation (NIV) will be screened for inclusion.
Upon consent, the patient will be randomized to receive the ordered SABD via a JN (MistyFast, Carefusion-BD, CA) or VMN (Aerogen Ultra, Aerogen, Galway, Ireland).
Included subjects will receive therapy with a mouthpiece interface. In the case a patient is unable to tolerate, maintain a tight seal around the mouthpiece or otherwise not perform aerosol therapy with a mouthpiece, a valved-aerosol mask (I-Guard aerosol mask, Salter Labs, Lake Forest, IL) will be utilized.
Subjects that require NIV, whether on admission to the ED or in the face of escalating therapy, will receive NIV via a non-vented, oronasal mask and the allocated nebulizer will be placed distal to the leak in the NIV circuit (between the mask and circuit). Patients will receive positive expiratory and/or inspiratory pressure at specific settings determined by the prescribing physician and clinical team.
Subjects will be re-evaluated and clinical data collected following delivery of the initial SABD treatment that includes signs of possible side effects.
The prescribing physician and clinical team will determine the need for additional SABD therapy beyond the initial therapy. Subjects indicated and ordered for additional administration of SABD will continue to receive SABD with the randomly allocated aerosol delivery device. Subjects will be re-evaluated and assessed for possible side effects after delivery of the additional SABD.
The initial order, as well as all subsequent orders for SABD medication will be at the discretion of the physician and clinical team. The type and dosage of medication and the approximate timing of medication delivery designated in the study protocol is according to and correlates with the standard practices. The process of determining need by the clinical team and administering additional SABD, followed by evaluation, will continue up to a total of four SABD treatments. If at any point following a SABD treatment, the clinical team assesses the subject and determines that no additional therapy is indicated, the subject will not receive additional SABD. Clinical data will be collected following each SABD administered (approximately every 30 minutes) and conclude at 120 min after randomization.
Subjects requiring the need for endotracheal intubation and mechanical ventilator support, immediate or in escalation of support, will be at the discretion of the attending physician. Subjects requiring endotracheal intubation as escalation of therapy following study enrollment will be included in the study analysis. Those subjects requiring the immediate need for endotracheal intubation prior to randomization will be excluded from the study.
Individualized decision regarding hospitalization or discharge to home will be according to the attending physician. Subjects admitted to the hospital for continued inpatient care will continue to receive nebulized bronchodilator therapy, as indicated and ordered, with an aerosol delivery device according to the MWHC bronchodilator protocol and standard practices.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
i. Patients ordered to receive short-acting bronchodilator therapy ii. Patients ≥ 40 years of age iii. Patients with a self-reported history of COPD and/or patients with diagnosed/suspected COPD iv. Patients whose FEV1 is ≤ 50% of predicted or are unable to perform FEV1 maneuver because of airflow-associated respiratory distress or NIV use
Exclusion Criteria:
i. Patients whose indication for SABD therapy is for a clinical indication other than COPD ii. The immediate need for intubation iii. Pregnant women iv. Non-English speakers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Jet nebulizer
short-acting bronchodilator (albuterol and/or ipratropium bromide) according to standard of care practices and physician discretion will be administered with a jet nebulizer
|
short-acting bronchodilator medication delivered with a jet nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask
Other Names:
|
Active Comparator: Vibrating Mesh Nebulizer
short-acting bronchodilator (albuterol and/or ipratropium bromide) according to standard of care practices and physician discretion will be administered with a vibrating mesh nebulizer
|
short-acting bronchodilator medication delivered with a vibrating mesh nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalization rate
Time Frame: through study completion (approx 1 year)
|
hospitalization rate among COPD exacerbation patients in the ED receiving SABD via jet nebulizer versus those receiving SABD via VMN
|
through study completion (approx 1 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU admission
Time Frame: through study completion (approx 1 year)
|
Percent of patients with COPD exacerbation treated with SABD via VMN versus JN admitted to an intensive care environment
|
through study completion (approx 1 year)
|
Hospital length of stay
Time Frame: through study completion (approx 1 year)
|
Hospital length of stay for patients with COPD exacerbation treated with SABD via VMN versus JN
|
through study completion (approx 1 year)
|
NIV in escalation of respiratory support
Time Frame: through study completion (approx 1 year)
|
Percentage of patients with COPD exacerbation treated with SABD via VMN versus JN that require NIV in escalation of respiratory support
|
through study completion (approx 1 year)
|
Duration of NIV support
Time Frame: through study completion (approx 1 year)
|
Duration of NIV support in patients with COPD exacerbation treated with SABD via VMN versus JN
|
through study completion (approx 1 year)
|
Intubation in escalation of respiratory support
Time Frame: through study completion (approx 1 year)
|
Percentage of patients with COPD exacerbation treated with SABD via VMN versus JN that require intubation in escalation of respiratory support
|
through study completion (approx 1 year)
|
Percentage change in FEV1
Time Frame: through study completion (approx 1 year)
|
Percentage change in FEV1 in patients with COPD exacerbation treated with SABD via VMN versus JN
|
through study completion (approx 1 year)
|
Amount of short-acting bronchodilator medication
Time Frame: through study completion (approx 1 year)
|
The amount of SABD aerosol therapy administered to patients with COPD exacerbation treated with SABD via VMN versus JN
|
through study completion (approx 1 year)
|
Hospital readmission within 30 days
Time Frame: through study completion (approx 1 year)
|
Percentage of patients treated with SABD via VMN versus JN that are readmitted to the hospital within thirty days of discharge
|
through study completion (approx 1 year)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eric J Kriner, RRT, MedStar Washington Hospital Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-281
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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