Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
Aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. The objective of this study was to evaluate inhaled bronchodilator and mucolytic agents delivered through a ventilator system.

Detailed Description
-----------------
Aerosolized medication is used widely to patients with respiratory illness and admitted in the intensive care unit, and includes bronchodilators, steroids, mucolytics, and antibiotics. Aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. Only few clinical trials on aerosol delivery deposition were published in the last decades. In addition, inhaled bronchodilators, mucolytics, antibiotics, and steroids are often administered to ventilated patients in the intensive care units in Taiwan, but they are never studied. Therefore, the aim of this study was to evaluate inhaled bronchodilator and mucolytics (acetylcystine) delivered by a jet nebulizer through a ventilator system to intubated patients.

Official Title
-----------------
Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Salbutamol
* Drug: Acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanical ventilated patients with an endotracheal tube intubated Receiving aerosol therapy with salbutamol or acetylcystine On relatively stable medical condition Exclusion Criteria: Pregnant Unstable hemodynamic status (e.g. blood pressure <100/60 mmHg, under Intra-aortic balloon pump) Infected with airborne pathogens (e.g. tuberculosis or Influenza virus) Poor oxygenation (fraction of inspiratory oxygen >0.8, under high frequency oscillatory ventilation, or extracorporeal membrane oxygenation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug depositions<br>Aerosol drug deposited delivered on the inhaled and exhaled filters and protective filters were evaluated. Salbutamol and Acetylcysteine were delivered by a jet nebulizer through a mechanical ventilator. | Drug: Salbutamol<br>* Salbutamol (albuterol ) was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.<br>* Other names: albuterol;Drug: Acetylcysteine<br>* Acetylcystine was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.<br>* Other names: Mucomyst;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhaled drug dose | Drug depositions in inspiratory filters were analyzed by a spectrophotometer. | Inhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exhaled drug dose | Drug depositions in expiatory filters were analyzed by a spectrophotometer. | Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes |