跳至主要内容
临床试验/NCT02987036
NCT02987036已完成不适用

Administration of Beta-agonistic Drug Using Two Different Nebulizer Technologies: Effects on Lung Mechanics

Southeast University, China1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

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

Experimental

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

Other

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

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Liu

Dr.

Southeast University, China

研究点 (1)

Loading locations...

相似试验