Airway Clearance Devices for Airway Blockage

Overseen By Lauren Harnois, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Pregnant, SVC <10 mL/kg, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Until discharge from the hospital

64 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for airway clearance devices?

Research shows that devices like the Acapella and Flutter, which use oscillatory positive expiratory pressure (OPEP), help clear mucus by creating vibrations that loosen it, making it easier to expel. These devices have been compared and shown to effectively aid in mucus clearance in various studies. ^{1 2 3 4 5}

Is the use of airway clearance devices generally safe for humans?

A study on an oscillatory device for COPD patients found no significant differences in side effects or exacerbations, suggesting it is generally safe for use in humans. ^{1 2 3 6 7}

How is the Airway Clearance Devices treatment different from other treatments for airway blockage?

The Airway Clearance Devices treatment is unique because it uses devices that create oscillations (vibrations) in the airways to help clear mucus, which is different from traditional methods that may not use such mechanical oscillations. These devices, like the Acapella and Flutter, use different mechanisms to generate these oscillations, such as a vibrating steel ball or a counterweighted plug, making them distinct in their approach to facilitating airway clearance. ^{1 2 3 7 8}

What is the purpose of this trial?

This pilot study aims to compare the ability of a higher oscillatory index device versus a lower oscillatory index device on airway secretion clearance and other clinically significant outcomes.

Eligibility Criteria

This trial is for adults over 18 with difficulty clearing airway secretions after being on a breathing machine. They must have specific scores indicating they need help with secretion clearance and can follow instructions. Pregnant individuals or those unable to breathe deeply enough are excluded.

Inclusion Criteria

Secretion score of at least 5 post extubation

Respiratory assess and treat (RAAT) score of at least 10

Exclusion Criteria

I am unable to understand or follow instructions.

Slow vital capacity (SVC) of <10 mL/kg

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a high or low oscillatory index device for airway secretion clearance

Until discharge from the hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment until hospital discharge

Until discharge from the hospital

Treatment Details

Interventions

• High Oscillatory Index Device
• Low Oscillatory Index Device

Trial Overview The study is testing two devices designed to help clear mucus from the airways: one creates high-frequency vibrations, while the other has lower frequency. The goal is to see which device works better at helping patients clear their airways.

Participant Groups

Group I: High Oscillatory Index Device Experimental Treatment 1 Intervention

Patients in this arm will receive a device that vibrates with high oscillatory index.

Group II: Low Oscillatory Index Device Active Control 1 Intervention

Patients in this arm will receive a device that vibrates with low oscillatory index.

High Oscillatory Index Device is already approved in United States, European Union for the following indications:

Approved in United States as High Oscillatory Index Device for:

• Cystic Fibrosis
• Diffuse Bronchiectasis
• Chronic Obstructive Pulmonary Disease
• Neuromuscular Disorders

Approved in European Union as High-Frequency Chest Compression Devices for:

• Cystic Fibrosis
• Respiratory Conditions Associated with Neuromuscular Disorders

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Findings from Research

The Acapella and Flutter devices both effectively facilitate secretion removal through oscillatory positive expiratory pressure (PEP), but they exhibit statistically significant differences in mean pressure, amplitude, and frequency across various flow rates, although these differences may not be clinically significant.

The Acapella device offers advantages over the Flutter, particularly at low expiratory flows, as it produces a more stable waveform and is not affected by gravity, making it potentially easier for patients to use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance comparison of two oscillating positive expiratory pressure devices: Acapella versus Flutter. Volsko, TA., DiFiore, J., Chatburn, RL.[2022]

The Flutter VRP1 and Shaker devices demonstrated similar mechanical performance in terms of pressure amplitudes when compared to each other, but both had higher values than the Acapella device, indicating they may provide more effective positive expiratory pressure (PEP) during use.

While Flutter VRP1 and Shaker had comparable oscillation frequencies, the Acapella device exhibited higher frequencies at low and intermediate pressures, suggesting it may be more effective in generating oscillations, although all devices performed similarly at high pressures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical behaviors of Flutter VRP1, Shaker, and Acapella devices. dos Santos, AP., Guimarães, RC., de Carvalho, EM., et al.[2013]

The Quake® device was found to be the most effective in clearing mucus from a tracheal model, outperforming Flutter® and Acapella® at similar frequencies and amplitudes, especially with gel-like mucus.

Coughing combined with oscillating positive expiratory devices significantly enhances mucus clearance, particularly when using high amplitude oscillations at moderate frequencies, which is beneficial for patients with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing performance of three oscillating positive expiratory pressure devices at similar amplitude and frequencies of oscillations on displacement of mucus inside trachea during cough. Ragavan, AJ.[2012]

The study evaluated various positive expiratory pressure (PEP) and oscillatory PEP (OPEP) devices, finding that while PEP devices generally performed similarly, OPEP devices showed significant variability in their performance characteristics, particularly in flow amplitude and frequency.

Devices like the Acapella DH, ShurClear, and Aerobika demonstrated superior mechanical performance, indicated by a higher oscillation index, which may correlate with better clinical outcomes for mucus clearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance Characteristics of Positive Expiratory Pressure Devices. Demchuk, AM., Chatburn, RL.[2023]

Using the Acapella device with a nebulizer attached to its distal end significantly reduced the delivery of aerosol medication to the lungs compared to placing the nebulizer between the mouthpiece and the Acapella or using the nebulizer alone.

The study, involving 10 healthy male subjects, found that the configuration of the nebulizer affects how well aerosol medication is deposited in different lung regions, with the recommended setup leading to up to a 3-fold decrease in deposition in key areas of the lungs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scintigraphic assessment of radio-aerosol pulmonary deposition with the acapella positive expiratory pressure device and various nebulizer configurations. Mesquita, FO., Galindo-Filho, VC., Neto, JL., et al.[2016]

The new oscillatory device (Pulsehaler) was found to be safe and significantly improved 6-minute walk (6MW) performance in patients with moderate-to-very severe COPD, with 91% of participants showing a clinically significant improvement after treatment.

Patients using the oscillatory device also experienced significant enhancements in pulmonary function and health-related quality of life (HRQOL), particularly in dyspnea and mastery, compared to a control device that provided continuous positive air pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD. Fridlender, ZG., Arish, N., Laxer, U., et al.[2012]

The study evaluated six different oscillatory positive expiratory pressure (OPEP) devices and found that the Flutter, Gelomuc, and Pari devices performed similarly well, achieving optimal oscillation frequencies and positive expiratory pressure (PEP) values more frequently than the others.

The effectiveness of these devices for airway clearance may vary based on the selected device and its resistance settings, indicating that choosing the right OPEP device is crucial for maximizing therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 6 Oscillatory Positive Expiratory Pressure Devices During Active Expiratory Flow. Poncin, W., Reychler, G., Liistro, M., et al.[2021]

High-frequency airway clearance devices, which use either positive or negative pressure to help clear mucus from the airways, are now standard care despite a lack of strong clinical evidence supporting their efficacy after over 20 years of research.

No single airway clearance technique has been proven superior, highlighting the need for further studies on patient preferences and cost-effectiveness to determine the best practices for different situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency assisted airway clearance. Chatburn, RL.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Performance comparison of two oscillating positive expiratory pressure devices: Acapella versus Flutter. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mechanical behaviors of Flutter VRP1, Shaker, and Acapella devices. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Comparing performance of three oscillating positive expiratory pressure devices at similar amplitude and frequencies of oscillations on displacement of mucus inside trachea during cough. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Performance Characteristics of Positive Expiratory Pressure Devices. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Scintigraphic assessment of radio-aerosol pulmonary deposition with the acapella positive expiratory pressure device and various nebulizer configurations. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of 6 Oscillatory Positive Expiratory Pressure Devices During Active Expiratory Flow. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

High-frequency assisted airway clearance. [2018]