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Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Salbutamol
Acetylcysteine
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Chiayi Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug depositions

Arm Description

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.

Outcomes

Primary Outcome Measures

Inhaled drug dose
Drug depositions in inspiratory filters were analyzed by a spectrophotometer.

Secondary Outcome Measures

exhaled drug dose
Drug depositions in expiatory filters were analyzed by a spectrophotometer.

Full Information

First Posted
June 20, 2016
Last Updated
January 30, 2017
Sponsor
Chang Gung University
Collaborators
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02818270
Brief Title
Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation
Official Title
Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University
Collaborators
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug depositions
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Salbutamol
Other Intervention Name(s)
albuterol
Intervention Description
Salbutamol (albuterol ) was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.
Intervention Type
Drug
Intervention Name(s)
Acetylcysteine
Other Intervention Name(s)
Mucomyst
Intervention Description
Acetylcystine was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.
Primary Outcome Measure Information:
Title
Inhaled drug dose
Description
Drug depositions in inspiratory filters were analyzed by a spectrophotometer.
Time Frame
Inhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes
Secondary Outcome Measure Information:
Title
exhaled drug dose
Description
Drug depositions in expiatory filters were analyzed by a spectrophotometer.
Time Frame
Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Ling Lin, MSc
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiayi Chang Gung Memorial Hospital
City
Chiayi
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

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