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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two devices designed to clear mucus from the airways, potentially easing breathing. The High Oscillatory Index Device vibrates more strongly than the Low Oscillatory Index Device. The study aims to determine which device is more effective for individuals with blocked airways. Those who struggle with mucus clearance and recognize this daily challenge are ideal candidates for the trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance daily life for others facing similar issues.

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 prior data suggests that these airway clearance devices are safe?

Research has shown that high-frequency chest wall oscillation (HFCWO) devices, such as the high oscillatory index device, are commonly used in the United States and have recently gained popularity in the UK and Europe. These devices are generally safe and assist patients by moving mucus out of their lungs.

For the low oscillatory index device, studies indicate that while it helps clear airways, users might require more antibiotics for chest infections compared to other methods. This suggests that although the device is safe, it might not be as effective in preventing infections.

Both devices operate by vibrating at different speeds to help clear airways. They are generally considered safe, and most people find them easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these airway clearance devices because they offer a new approach to managing airway blockages through oscillation therapy. Unlike traditional chest physiotherapy or mechanical ventilation, these devices use a unique vibratory mechanism to help clear mucus effectively. The High Oscillatory Index Device and the Low Oscillatory Index Device provide a range of oscillation intensities, giving healthcare providers flexibility to match patient needs. This innovative method could improve patient comfort and outcomes by potentially reducing the time required to clear airways and enhancing overall lung function.

What evidence suggests that this trial's devices are effective for airway blockage?

This trial will compare the effectiveness of two different airway clearance devices. Research has shown that high-frequency chest wall oscillation (HFCWO) devices, similar to the high oscillatory index device tested in this trial, can help clear airways in conditions like cystic fibrosis (CF). These devices gently shake the chest to loosen and remove mucus. One study found that HFCWO effectively helped patients with CF and those on long-term breathing machines clear their airways.

The low oscillatory index device, another treatment option in this trial, also aids in airway clearance by using vibrations to move mucus. Studies indicate that patients using devices like Acapella, which resembles the low oscillatory index device, experienced fewer serious breathing problems over time. Both types of devices in this trial have shown promise in improving breathing by clearing blocked airways. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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The. Vest Airway Clearance System provides high-frequency chest compression using an inflatable vest and an air-pulse generator. Large-bore ...