Evaluating the Utilization and Effectiveness of Breath-actuated Nebulizers in Acute COPD Exacerbations
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Total number of nebulizer treatments administered
研究概览
简要总结
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).
详细描述
Overview:
Effective administration of aerosolized medications depends on the patient's age, physical and cognitive ability the delivery system, and the patient-device interface. Physical ability means the patient's ability to use a specific device, based on factors such as inspiratory volumes and flows, hand-breath coordination, or ability to use a mouthpiece. Cognitive ability indicates the patient's understanding of how and when to use a device and medication. Airway size, respiratory rate, inspiratory flow rate, and breathing pattern create substantial challenges for effective aerosol delivery. While most aerosol generators can be used with all age groups, special consideration should be given to young children because they cannot master the complex steps required for adequate delivery of aerosol treatments. A mouthpiece may be used for patients > 3 years who are able to cooperate, while a face mask is recommended for patients who cannot use a mouthpiece. Face masks should be properly fitted with minimal leak, particularly avoiding aerosol delivery into the eyes, to optimize inhaled dose. Aerosol generators are equally efficacious if they are age appropriate and used correctly. Regardless of age, patients need to demonstrate ability to seal the lips around the mouthpiece and ability to generate sufficient flow for the specific inhaler. However, the impact of breath-actuation on nebulizer utilization and outcomes vs. standard nebulizer has yet to be evaluated.
Per the American Association Respiratory Care (AARC) Clinical Practice Guidelines for Aerosol Delivery Device Selection for Spontaneously Breathing Patients: 2012, the "appropriate selection of an aerosol generator" is reflected by 1) a positive clinical outcome after aerosol therapy, 2) use of proper technique in applying aerosol delivery system, 3) patient adherence with application of aerosol delivery systems.
Admissions to Rhode Island Hospital (RIH) for respiratory failure due to chronic obstructive pulmonary disease (COPD) exacerbations are common. COPD exacerbations are typically treated with a combination of intravenous or oral corticosteroids and inhaled bronchodilators. Inhaled bronchodilators, including Albuterol, Atrovent and Combivent (a combination of Albuterol and Atrovent), are usually administered as a nebulized solution until there is clinical improvement to the point where patients can be transitioned back to their outpatient metered dose inhalers (MDIs). Standard nebulizers are delivered as a continuous stream of inhaled medication through an interface that the patient holds in his/her mouth. As the medication is delivered irrespective of whether the patient is inhaling or exhaling, a significant portion that is intended to be deposited into the lung never reaches its destination.
Recently, Breath Actuated Nebulizers (BANs) have been developed to provide nebulized medications only when the patient inhales. Industry-sponsored studies, included those that have been funded by Monaghan Medical (Monaghan Medical Corporation, Plattsburgh, NY), the manufacturer of the AeroEclipse II BAN, have demonstrated that nebulized medications delivered via a BAN device have improved drug deposition to more distal areas of the lungs. Patients admitted to the hospital with an acute COPD exacerbation have improved lung hyperinflation and tachypnea when nebulized bronchodilators are administered through a BAN device compared with a continuous flow nebulizer. In addition, BAN use has been associated with a cost savings, in part due to improved workflow efficiency for respiratory therapists and a decrease in the overall number of nebulizer treatments needed. However, there is a paucity of data that address more clinically-relevant outcomes in patients hospitalized with COPD exacerbations that are treated with bronchodilators delivered by BANs versus continuous flow nebulizers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Total number of nebulizer treatments administered
时间窗: Through study completion, an average of 6 months
Medication administration data gathered from electronic medical record (EMR) after patient discharge
Time to nebulizer treatment de-escalation (i.e. standing order to prn order to discontinuation)
时间窗: 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
Time to return to baseline supplemental oxygen requirement
时间窗: 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
次要结局
- Hospital length of stay (LOS)(Through study completion, an average of 6 months)
- 6-month post-discharge data(Through study completion, an average of 6 months)
- 30-day (+ 7 days) readmission rate(Through study completion, an average of 6 months)
- Patient-reported ease of device use (USE Questionnaire)(Through study completion, an average of 6 months)
- Hospital Mortality(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)