CPAP for Excessive Dynamic Airway Collapse

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Asthma, COPD, GERD, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 3 months

32 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this protocol is to perform a prospective, randomized, double-blinded, pacebo-controlled clinical trial to determine the influence of a non-invasive positive pressure ventilation device on exercise capacity and symptoms in adult patients with ECAC. Primary outcome will include the total distance traversed by the study subject during a standard 6-minute walk test, and secondary outcomes will include peak flow measurement and symptom reporting before and after the exercise testing. The study will focus on the use of continuous positive airway pressure (CPAP) device. CPAP is FDA-approved for the treatment of various medical conditions, including obstructive sleep apnea and heart failure, but is not FDA-approved for the treatment of ECAC. The study will enroll 32 ambulatory study subjects with confirmed ECAC at the BIDMC, and each study subject will be monitored for up to 3 months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have poorly-controlled respiratory conditions or certain heart issues, you may not be eligible to participate.

What data supports the effectiveness of the treatment Continuous Positive Airway Pressure (CPAP) for Excessive Dynamic Airway Collapse?

Research shows that CPAP is effective in treating various respiratory conditions, such as acute respiratory failure and acute pulmonary edema, by improving breathing and reducing the need for more invasive procedures like intubation. ^{1 2 3 4 5}

Is CPAP generally safe for humans?

CPAP is generally considered safe for humans, as it is widely used to treat breathing disorders like sleep apnea and respiratory distress. However, it can cause some side effects, such as pressure ulcers from the mask and potential effects on facial development. ^{4 6 7 8 9}

How is CPAP treatment unique for excessive dynamic airway collapse?

CPAP treatment is unique because it provides continuous air pressure to keep the airways open, which can help prevent the need for more invasive procedures like intubation. Unlike other treatments, CPAP is non-invasive and can be used at home, making it a convenient option for managing airway issues. ^{4 5 10 11 12}

Eligibility Criteria

Adults over 18 with ECAC confirmed by bronchoscopy or CT scan, who can walk more than 140m in six minutes and have never used CPAP devices. Excluded are those with conditions affecting the trial's assessments, poorly-controlled respiratory issues, recent infections, certain heart rhythm problems, sensitivity to sedation drugs for bronchoscopy, or severe physical limitations not related to breathing.

Inclusion Criteria

You have been diagnosed with ECAC through a bronchoscopy or CT scan.

You are over 18 years old.

You are scheduled to have a bronchoscopy as part of your regular medical care.

Exclusion Criteria

You have a health problem that makes it hard to finish the required check-ups.

You cannot walk more than 140 meters (150 yards) in 6 minutes.

You have a heart rhythm problem that could be dangerous during physical activity or training.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial evaluation including PFTs, 6MWT, dynamic CT scan, and bronchoscopy to confirm ECAC diagnosis

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo CPAP calibration and perform 6MWT with either CPAP or sham-CPAP

3 months

Multiple visits (in-person) for CPAP calibration and 6MWT

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Continuous positive airway pressure (CPAP) device
• Sham-continuous positive airway pressure (CPAP) device

Trial Overview The study tests if a CPAP device improves exercise capacity in ECAC patients compared to a sham (fake) device. Participants will be randomly assigned to one of the two groups without knowing which one they're in and monitored during a standard 6-minute walk test among other measures.

Participant Groups

Group I: Group 1 Experimental Treatment 1 Intervention

This group will perform a 6MWT with CPAP

Group II: Group 2 Placebo Group 1 Intervention

This group will perform a 6MWT with a sham-CPAP

Continuous positive airway pressure (CPAP) device is already approved in United States, European Union, Canada for the following indications:

Approved in United States as CPAP for:

• Obstructive Sleep Apnea
• Heart Failure

Approved in European Union as CPAP for:

• Obstructive Sleep Apnea
• Heart Failure
• Respiratory Failure

Approved in Canada as CPAP for:

• Obstructive Sleep Apnea
• Heart Failure

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Findings from Research

Nurses in a general medical ward developed collaborative strategies to effectively implement continuous positive airway pressure (CPAP) therapy, emphasizing teamwork and patient-centered care to enhance treatment outcomes.

Building a strong alliance with patients was identified as crucial for preventing treatment failure, highlighting the importance of addressing patients' physical and emotional needs during CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurses' strategies to enable continuous positive airway pressure therapy in a general medical ward context: A qualitative study. Feldt, A., Köhler, AK., Bergstrand, S.[2023]

In a pilot study involving 12 acute stroke patients, CPAP was well tolerated, with 84% acceptance and an average usage of 5.2 hours, indicating its potential for managing respiratory issues in this population.

While CPAP showed some benefits in reducing respiratory disturbances and blood pressure variability, caution is advised due to significant decreases in cerebral blood flow velocity at higher CPAP pressures, suggesting potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance, effectiveness and safety of continuous positive airway pressure in acute stroke: a pilot study. Scala, R., Turkington, PM., Wanklyn, P., et al.[2016]

Both the Venturi-like flow generator and Boussignac's device were effective in improving clinical and gasanalytic parameters in patients with Acute Respiratory Failure due to Acute Cardiogenic Pulmonary Edema, with significant improvements noted within the first hour of treatment.

The Boussignac's device was found to have better tolerability compared to the Venturi-like flow generator, suggesting it could be a preferred option for use in settings where more complex equipment is unavailable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuous positive airway pressure in acute pulmonary edema. application in a general medical ward]. Lari, F., Giostra, F., Bragagni, G., et al.[2011]

An improvised CPAP system, tested on 10 healthy volunteers, successfully maintained positive airway pressure for 30 minutes without causing any significant changes in heart rate, oxygen saturation, or end-tidal CO2 levels, indicating its safety for use.

Participants reported the system as comfortable, with an average comfort rating of 4.0 out of 5, suggesting it could be a viable option for providing respiratory support in low-resource settings where traditional ventilators are unavailable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of improvised CPAP (iCPAP) via face mask for the treatment of adult respiratory distress in low-resource settings. Milliner, BH., Bentley, S., DuCanto, J.[2020]

In a study of 123 patients with acute hypoxemic respiratory insufficiency, CPAP showed early improvements in oxygen levels compared to standard oxygen therapy, but did not reduce the need for intubation or improve overall clinical outcomes.

Patients receiving CPAP experienced more adverse events than those on standard therapy, highlighting potential safety concerns despite the initial physiological benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: A randomized controlled trial. Delclaux, C., L'Her, E., Alberti, C., et al.[2022]

A systematic review of 54 studies across 19 countries identified key barriers to implementing CPAP for neonates in low-resource settings, including unreliable electricity and lack of bioengineering support, while highlighting the importance of training and mentorship for healthcare providers as facilitators.

Nasal trauma was the most common complication reported, emphasizing the need for user-friendly device designs and access to necessary supplies to ensure safe and effective use of CPAP in these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences with implementation of continuous positive airway pressure for neonates and infants in low-resource settings: A scoping review. Dada, S., Ashworth, H., Sobitschka, A., et al.[2021]

The study measured the contact pressures exerted by a CPAP mask on a rigid phantom head, revealing that pressure increases significantly in areas like the zygomatic region and nasal bridge as force is applied, which could impact facial development and cause pressure ulcers.

The findings highlight that the pressure distribution from CPAP masks is not uniform across the face, suggesting a need for improved mask design to balance effective ventilation with minimizing potential side effects on the skin and underlying tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental determination of the contact pressures produced by a nasal continuous positive airway pressure mask: A case study. Savoldi, F., Svanetti, L., Tsoi, JKH., et al.[2022]

CPAP therapy is effective for treating moderate to severe obstructive sleep apnea, but standard mask designs often do not fit individual patients well, which can affect treatment compliance and effectiveness.

Customizing CPAP masks to fit individual characteristics, such as face shape and skin sensitivity, could improve patient comfort and reduce skin damage, with emerging technologies like 3D printing showing promise for creating tailored solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mask interface for continuous positive airway pressure therapy: selection and design considerations. Ma, Z., Drinnan, M., Hyde, P., et al.[2019]

The nurse practitioner-led MENDS intervention, which included virtual motivational support for CPAP users, was feasible with high completion rates and minimal technical issues, indicating it could be a practical approach to improve adherence in patients with Obstructive Sleep Apnea (OSA).

While the study did not find statistically significant differences in CPAP adherence or patient-reported outcomes between the MENDS and usual care groups, higher adherence was linked to improvements in fatigue, sleep disturbance, and anxiety, suggesting that better CPAP use can enhance overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse practitioner-led, virtually delivered, motivational enhancement and device support intervention to improve CPAP adherence: A feasibility randomized control trial. Miller, JN., Kupzyk, K., Zheng, C., et al.[2023]

The study compared two CPAP systems (threshold resistor and flow resistor) at various altitudes, finding that the threshold resistor maintained consistent pressure levels, making it more reliable for use in air ambulances.

In contrast, the flow resistor CPAP delivered higher pressures than set at high altitudes, which could lead to variability in treatment effectiveness, suggesting that threshold resistor devices are preferable for patient care during flight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulated flying altitude and performance of continuous positive airway pressure devices. Sehlin, M., Brändström, H., Winsö, O., et al.[2019]

In a study involving 36 outpatients with obstructive sleep apnea syndrome (OSAS), automatic CPAP machines using estimated reference pressures were found to be as effective as those using fixed pressures in alleviating sleep and breathing disorders.

The results suggest that automatic CPAP can be effectively administered without the need for a titration sleep study, allowing for easier adjustments based on individual characteristics, although one patient did experience treatment failure due to an underestimated pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of automatic continuous positive airway pressure therapy that uses an estimated required pressure in the treatment of the obstructive sleep apnea syndrome. Sériès, F., Marc, I.[2019]

Common CPAP devices can pose a risk of rebreathing harmful gases if the device fails, as shown by a study testing four different CPAP systems and their exhalation ports.

The study found that after CPAP failure, oxygen levels in the mask dropped significantly, indicating a dangerous buildup of carbon dioxide, which could be prevented by adding a passive valve to the system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential rebreathing after continuous positive airway pressure failure during sleep. Farré, R., Montserrat, JM., Ballester, E., et al.[2019]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Nurses' strategies to enable continuous positive airway pressure therapy in a general medical ward context: A qualitative study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Acceptance, effectiveness and safety of continuous positive airway pressure in acute stroke: a pilot study. [2016]

3. Italy pubmed.ncbi.nlm.nih.gov

[Continuous positive airway pressure in acute pulmonary edema. application in a general medical ward]. [2011]

4. England pubmed.ncbi.nlm.nih.gov

A pilot study of improvised CPAP (iCPAP) via face mask for the treatment of adult respiratory distress in low-resource settings. [2020]

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

Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: A randomized controlled trial. [2022]

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

Experiences with implementation of continuous positive airway pressure for neonates and infants in low-resource settings: A scoping review. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Experimental determination of the contact pressures produced by a nasal continuous positive airway pressure mask: A case study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Mask interface for continuous positive airway pressure therapy: selection and design considerations. [2019]

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

Nurse practitioner-led, virtually delivered, motivational enhancement and device support intervention to improve CPAP adherence: A feasibility randomized control trial. [2023]

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

Simulated flying altitude and performance of continuous positive airway pressure devices. [2019]

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

Efficacy of automatic continuous positive airway pressure therapy that uses an estimated required pressure in the treatment of the obstructive sleep apnea syndrome. [2019]

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

Potential rebreathing after continuous positive airway pressure failure during sleep. [2019]