Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

NCT ID: NCT02818270

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

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

Acetylcysteine

Intervention Type DRUG

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

Interventions

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Salbutamol

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

Intervention Type DRUG

Acetylcysteine

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

Intervention Type DRUG

Other Intervention Names

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albuterol Mucomyst

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Chang Gung University

OTHER

Sponsor Role lead

Responsible Party

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Hui-Ling Lin

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hui-Ling Lin, MSc

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

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Chiayi Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NMRPD1E0911

Identifier Type: -

Identifier Source: org_study_id

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