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Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

Sponsor
Chang Gung University (Other)
Overall Status
Completed
CT.gov ID
NCT02818270
Collaborator
Chang Gung Memorial Hospital (Other)
30
Enrollment
1
Location
1
Arm
7
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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
N/A

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

Study Type:
Interventional
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 :
Jun 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 31, 2016

Arms and Interventions

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 Names:
  • albuterol

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Chiayi Chang Gung Memorial Hospital Chiayi Taiwan

    Sponsors and Collaborators

    • Chang Gung University
    • Chang Gung Memorial Hospital

    Investigators

    • Principal Investigator: Hui-Ling Lin, MSc, Chang Gung University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hui-Ling Lin, Assistant professor, Chang Gung University
    ClinicalTrials.gov Identifier:
    NCT02818270
    Other Study ID Numbers:
    • NMRPD1E0911
    First Posted:
    Jun 29, 2016
    Last Update Posted:
    Feb 1, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Acetylcysteine
    Albuterol
    N-monoacetylcystine

    Study Results

    No Results Posted as of Feb 1, 2017