A Pilot Study of Medicated Aerosol Delivery Using A Jet Nebulizer Versus A Vibrating Mesh Nebulizer in COPD Exacerbation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Hospitalization rate
研究概览
简要总结
Delivery of inhaled short-acting bronchodilators (SABD) is standard of care in the emergency department (ED) for exacerbation of COPD, the goal of such being rapid reversal of airflow obstruction. However, current guidelines for the delivery of SABDs in spontaneously breathing patients make no distinction whether these medications should be delivered via metered dose inhaler (MDI) or jet nebulizer (JN), the specific medication delivery device having no significant effect on hospital admission or reversal of flow obstruction. However, advancements in nebulizer design, namely FDA-approved vibrating mesh technology, have demonstrated significant improvements relative to JNs and metered dose inhalers in efficiency and amount of drug delivered in in vivo and in vitro studies. Currently there are no clinical trials comparing the use of vibrating mesh nebulizers (VMN) to JNs and their effect on clinically important outcomes. This prospective randomized controlled pilot trial seeks to determine if there are differences in hospital admission due to COPD when a vibrating mesh nebulizer is used versus a jet nebulizer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Hospitalization rate
时间窗: 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
次要结局
- Percentage change in FEV1(through study completion (approx 1 year))
- Amount of short-acting bronchodilator medication(through study completion (approx 1 year))
- ICU admission(through study completion (approx 1 year))
- Hospital length of stay(through study completion (approx 1 year))
- NIV in escalation of respiratory support(through study completion (approx 1 year))
- Duration of NIV support(through study completion (approx 1 year))
- Intubation in escalation of respiratory support(through study completion (approx 1 year))
- Hospital readmission within 30 days(through study completion (approx 1 year))