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Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02818270
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Hui-Ling Lin, Chang Gung University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Salbutamol Drug: Acetylcysteine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Salbutamol
Salbutamol (albuterol ) was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.
Other Name: albuterol

Drug: Acetylcysteine
Acetylcystine was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.
Other Name: Mucomyst


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818270


Locations
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Taiwan
Chiayi Chang Gung Memorial Hospital
Chiayi, Taiwan
Sponsors and Collaborators
Chang Gung University
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Hui-Ling Lin, MSc Chang Gung University
More Information
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Responsible Party: Hui-Ling Lin, Assistant professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT02818270    
Other Study ID Numbers: NMRPD1E0911
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Chronic Disease
Disease Attributes
Pathologic Processes
Acetylcysteine
Albuterol
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents