Administration of Beta-agonistic Drug Using Two Different Nebulizer Technologies: Effects on Lung Mechanics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change of intrinsi PPPE
研究概览
简要总结
The purpose of this study is to find out weather differences in administration nebulizer technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables (Compliance, resistance and PEEPi) during controlled mechanical ventilation.
详细描述
The delivery of aerosols has a two fold appeal as it is distributed direct to the tracheo- bronchial tree and alveolar epithelium. The drug is then rapidly absorbed by the circulation avoiding the first pass entero-hepatic metabolic effect.
The systemic effects may be regarded as a side effect in the case were the primary therapeutic target is aimed at the bronchial tree as is the case with broncho-active drugs, such as β2-stimulants.
The ability of particles to remain suspended in a gas can be predicted from their size, shape and density, coupled with the density and viscosity of the gas. The properties of an aerosol is commonly expressed as the Mass Median Aerosol Diameter MMAD, a measure of the average particle size and the geometric standard deviation. It is calculated from the cumulative particle size curve1. The MMAD will give a reliable estimate of the likely deposition of the drug along the tracheo-bronchial tree. A particle size >5 will likely deposit in the upper airways, while particles with an MMAD of 2-5 is likely to deposit in the tracheo-bronchial tree2.
Jet nebulizers are the most commonly used devices for aerosol therapy. However, the MMAD generated by this device is unpredictable, often leading to the drug being deposited in the ventilator circuit or endotracheal tube3.
An alternative is the vibrating mesh nebulizer, which is based on a high frequency vibrating piezoelectric crystal. The crystal will vibrate a micron mesh at a very high frequency. A micro pump will deliver a small volume of liquid from a reservoir into the vibrating mesh resulting in a very precise aerosol generation3.
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
- 15 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on mechanical ventilation for more than 48 hours
- •PEEPi ≥3 cm H2O and expected to remain on controlled mechanical ventilation for at least 24 hours.
排除标准
- •Severe chronic lung disease with chronic hypercapnia (PCO2>45 mm Hg), Chronic hypoxemia (PO2< 55mm Hg with FiO2=0,21), hospitalization within last 6 months for respiratory failure (PCO2>50; PO2<55mm Hg), Secondary polycythemia, severe pulmonary hypertension (mPAP >40 mm Hg.
- •Unable to obtain consent
- •Acute myocardial infarction
- •Severe congestive heart failure
- •Heart rate greater than maximal predicted heart rate MHR85 (MHR 85=0.85 x (220-age).
- •Burns over more than 40% of body surface area
- •Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
- •Allogenic bone marrow transplantation within 5 years prior to the study
- •Diffuse alveolar hemorrhage from vaculitis
- •Morbid obesity
- •Moribund, not expected to survive 24 hours
- •Daily use of beta agonists prior to hospitalization
- •Participation in other study
- •Chronic liver disease
- •Neuromuscular disease that impairs ability to breath without assistance (e.g. Cervical spine cord injury at level C5 and higher, Amyotrophic lateral sclerosis, Guillain-Barre syndrome or myasthenia gravis)
- •Pregnant or breast-feeding
研究组 & 干预措施
Aerogen
Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Aerogen
干预措施: Aerogen (Device)
Jet Nebulizer
Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet Nebulizer
干预措施: Jet nebulizer (Device)
结局指标
主要结局
change of intrinsi PPPE
时间窗: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
次要结局
- change of respiratory system Compliance(0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration)
- change of respioratory resistance(0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration)
研究者
Ling Liu
Dr.
Southeast University, China
