Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818270
• Other study ID #: NMRPD1E0911
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: January 30, 2017
• Start date: June 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2017
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chiayi Chang Gung Memorial Hospital	Chiayi

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung University	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhaled drug dose	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	exhaled drug dose	Drug depositions in expiatory filters were analyzed by a spectrophotometer.	Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes