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Completed

NCT Number: NCT02818270

Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chiayi Chang Gung Memorial Hospital

Chiayi City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Salbutamol

Drug

Salbutamol (albuterol ) was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.

Other names: albuterol

acetylcysteine

Drug

Acetylcystine was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.

Other names: Mucomyst

Primary outcomes

  1. 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

  1. exhaled drug dose

    Time frame: Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes

    Drug depositions in expiatory filters were analyzed by a spectrophotometer.

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2016
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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