Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

NCT02818270 | Completed DMC

• 1 other identifier: NMRPD1E0911
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• exhaled drug dose

  Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes

Study Arms (1)

Drug depositions

EXPERIMENTAL

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; Drug: Acetylcysteine

Interventions

Salbutamol DRUG

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

Also known as: albuterol

Drug depositions

Acetylcysteine DRUG

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

Also known as: Mucomyst

Drug depositions

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanical ventilated patients with an endotracheal tube intubated
• Receiving aerosol therapy with salbutamol or acetylcystine
• On relatively stable medical condition

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung University: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Chiayi Chang Gung Memorial Hospital

Chiayi City, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol; Acetylcysteine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Hui-Ling Lin, MSc

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 31, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)