Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

January 30, 2017 updated by: Hui-Ling Lin, Chang Gung University

Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chiayi, Taiwan
        • Chiayi Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Inhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung University

Collaborators

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRPD1E0911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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