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Clinical Trials/NCT02818270
NCT02818270
Completed
Not Applicable

Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator

Chang Gung University1 site in 1 country30 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Salbutamol
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Chang Gung University
Enrollment
30
Locations
1
Primary Endpoint
Inhaled drug dose
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 31, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hui-Ling Lin

Assistant professor

Chang Gung University

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

  • 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)

Arms & Interventions

Drug depositions

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.

Intervention: Salbutamol

Drug depositions

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.

Intervention: Acetylcysteine

Outcomes

Primary Outcomes

Inhaled drug dose

Time Frame: 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 Outcomes

  • exhaled drug dose(Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes)

Study Sites (1)

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