Delivery of Beta Agonists is Technique Sensitive (DOBATS)Mechanics

Respiratory Failure Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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.

Nebulizer therapy is often prescribed without proven effects or proper evaluation of result. Indeed, two large multicenter trial in acute lung injury patients were discontinued at interim analyses due to lack of effect4,5. This lack of effect may be due to the nebulizer technology (Jet nebulizer), the indication (ARDS), or primary outcome.

The investigators would like to compare the difference in therapeutic effect between these two devices as this has not been published previously. It is well known that the physical properties of the generated aerosol may differ widely, depending on device and technology used. Hence, even if the same amount of drug is administered, distribution and uptake will not be the same. It can further be expected that the therapeutic response will be different. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

• NCT number: NCT02987036
• Study type: Interventional
• Source: Southeast University, China
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Completion date: November 2016