Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Salbutamol; Drug: Acetylcysteine

• Registration Number: NCT02818270
• Lead Sponsor: Chang Gung University

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Primary Completion: 2016-12
• Study Completion: 2016-12-31
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug depositions	Salbutamol	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 depositions	Acetylcysteine	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.

Primary Outcome Measures

Name	Time	Method
Inhaled drug dose	Inhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes	Drug depositions in inspiratory filters were analyzed by a spectrophotometer.

Secondary Outcome Measures

Name	Time	Method
exhaled drug dose	Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes	Drug depositions in expiatory filters were analyzed by a spectrophotometer.

Trial Locations

Locations (1)

Chiayi Chang Gung Memorial Hospital; 🇨🇳 Chiayi, Taiwan