Introduction
Nebulization is the most effective method for delivering medications to patients suffering from respiratory disease. Nebulizers do not require special inhalation techniques; therefore, hospitals utilize a variety of nebulizer designs for medicinal delivery. One of these devices is called AeroEclipse, which can be operated via one of two different modes. The breath actuation mode generates aerosol only during the patient’s inspiration while the other mode allows for the continuous generation of aerosol particles regardless of the patient’s inspiratory and expiratory efforts. Also, the AeroEclipse has two different patient interfaces: the facemask and the mouthpiece. The hypothesis of this experiment is that operating the AeroEclipse at flow rate of 8 Liter/minute accompanied with breath actuation mode will maximize the emitted dose of albuterol sulfate.
Literature review
A high degree of dose-to-dose precision characterizes technological trends in device sophistication with systems achieving a reported 80% of lung deposition of emitted dose, leaving researchers a marginal area of improvement in which elements of ease of preparation, ease of use, lower-velocity aerosol delivery, dose counting/monitoring, patient education, convenience, and compliance have emerged.1 At this stage, the primary concern is how to most effectively leverage nebulizer design to systematically deliver medicine for greatest patient benefit in clinical settings. In a study comparing, small-volume nebulizers (SVN) and AeroEclipse II breath-activated nebulizer (BAN), the BAN model proved more effective in reducing lung hyperinflation and respiratory frequency, concluding that the BAN offered a higher respiratory capacity and bronchodilator value than the SVN design when used to treat patients suffering from exacerbations of COPD.2 BAN produces a finer particle mass, resulting in higher inspiratory capabilities, and an observed superiority in tracking physiological outcomes because of BAN use.2 Additional research corroborates this conclusion, highlighting the importance of nebulizer design and medication delivery efficacy in both clinical and home-care environments. Drug utilization is a central concern. Inhaled therapy in asthma patients, for instance, shows the dose requirement is about 50 times less than oral delivery, which is significantly reducing systemic exposure and potential side effects like tremor and tachycardia.3
For evaluating design effectiveness, realistic breathing conditions are used to test total drug deposition, accounting for key components of emitted drug, device loss, and exhaled/ambient drug loss.4These factors are key in determining maximum utility. In comparing nebulizer designs, including constant-output, breath-enhanced, and dosimetric categories, overall drug deposition outcomes differ. However, the AeroEclipse delivered the largest drug mass inhalation (2.5 times better performance than constant-output and breath-enhanced devices), as well as the lowest loss to ambient air rates.4 Comparative evaluations would be enhanced by utilizing controlled and systematic testing environments for design performance. In furthering practical nebulizer usage, these findings play a vital role in the safety and quality of patient care. Furthermore, in comparison, the BAN model proved advantageous in treating patients with asthma exacerbations; BAN promotes shorter treatment times and improved clinical scores, leading to decreased duration in emergency department stays, reduced demand for albuterol, and fewer hospitalizations overall.5
The goal of these devices is to improve medicinal delivery and reduce medicinal waste. Given this research foundation and having validated the BAN system as a superior delivery system, the next research step is to assess the AeroEclipse, to define the best available setup within this particular design. It is hypothesized that operating AeroEclipse at 8 Liter/ minute, using the breath actuation mode, will render the best result in terms of delivering the medication. This research will provide insight into how flow, device selection, and delivery mechanics impact medicinal utility outcomes.
Multiple test trials will be conducted in a laboratory setting to investigate best outcomes of drug delivery as determined by maximumly emitted dose and minimized dead volume (waste) in the nebulizer. Twenty trials will be divided into two different modes of actuation of the BAN nebulizer (continuous and breath actuation mode). First 10 trials will be in breath actuation mode. These 10 trials will further be divided into 5 with 6 liter/minute and the remaining 5 with 8 liter/minute. These 10 trials will utilize the aeroeclipse nebulizer (Trudell Medical International, London, Ontario, Canada), the electrically powered Simulator (Michigan Instrument Inc., Grand Rapid, MI), which will be connected to the test lung (dual adult, Michigan Instrument Inc., Grand Rapid MI) with a tubing. During the first ten trials, the breathing parameters of the lung model will be set as following tidal volume (Vt) = 800, respiratory rate = 20, and inspiratory to expiratory ratio 1:2. When the connection between the Simulator to the lung model is ready, it will be connected to the Aeroeclipse which need to be weighted using the scale (Mettler-Toledo, Columbus, OH). The Aeroeclipse will be connected to the air flow compensated Thorpemeter which is connected to the wall with standard 50 psi pressure before filling with 3 ml Normal Saline (Sodium Chloride), after filling and after finishing of 5 minutes nebulization,
The second ten trials will utilize air flow compensated Thorpe meter, scale, Normal saline and the Aeroeclipse which will set for continuous mode of nebulization. The second two sets of trials will not utilize the simulator and the test lung since nebulization will be in continuous mode. Out of these ten trials, five trials will utilize air flow of 6 liter/ minute, and the second five will utilize air flow of 8 liter/minute. The BAN will be filled with 3 ml of normal saline in each trial in order to verify the best outcome of the comparison. The breathing parameters of inspiratory to expiratory ratio is set to 1:2 during the ten trials. When the simulator is ready It will be connected to the Aeroeclipse which will need to be weighted using the scale (Mettler-Toledo, Columbus, OH). This will take place for each of the ten trials. It will then be filled with 3ml normal Saline and nebulization will take place till 5mins. This will continue till the completion of the process.. First five set of the trials will be using the breath actuation mode, which produces aerosol only when the patient breathes it in. During this mode, the flow meter will be set at an air flow of 6 Liter/minute. The second five set of trials will be in the same mode, but the flow meter will be set at an air flow of 8 Liter/minute. The third five set of trials will be using the continuous actuation mode, which produces and streams aerosol continuously to the patient, regardless of inhalation, resting, or exhalation. Here, the flow meter will be operated at a flow rate of 6 Liter/minute. Last, the fourth five set of trials will be using the same mode, but the flow meter will be set at 8 Liter/minute.
References:
- Mitchell JP, Nagel MW. Oral inhalation therapy: meeting the challenge of developing more patient-appropriate devices. Expert Rev Med Devices. 2009;6(2):147-55.
- Haynes JM. Randomized controlled trial of a breath-activated nebulizer in patients with exacerbation of COPD. Respir Care. 2012;57(9):1385-90.
- Everard ML. Aerosol delivery to children. Pediatr Ann. 2006;35(9):630-6.
- Rau JL, Ari A, Restrepo RD. Performance comparison of nebulizer designs: constant-output, breath-enhanced, and dosimetric. Respir Care. 2004;49(2):174-9.
- Titus MO, Eady M, King L, Bowman CM. Effectiveness of a breath-actuated nebulizer device on asthma care in the pediatric emergency department. Clin Pediatr (Phila). 2012;51(12):1150-4.
