32 Participants Needed

CPAP for Excessive Dynamic Airway Collapse

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

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.46789

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.45101112

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.
See 2 more

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.
See 6 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1Experimental Treatment1 Intervention
This group will perform a 6MWT with CPAP
Group II: Group 2Placebo Group1 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

Find a Clinic Near You

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

References

Nurses' strategies to enable continuous positive airway pressure therapy in a general medical ward context: A qualitative study. [2023]
Acceptance, effectiveness and safety of continuous positive airway pressure in acute stroke: a pilot study. [2016]
[Continuous positive airway pressure in acute pulmonary edema. application in a general medical ward]. [2011]
A pilot study of improvised CPAP (iCPAP) via face mask for the treatment of adult respiratory distress in low-resource settings. [2020]
Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: A randomized controlled trial. [2022]
Experiences with implementation of continuous positive airway pressure for neonates and infants in low-resource settings: A scoping review. [2021]
Experimental determination of the contact pressures produced by a nasal continuous positive airway pressure mask: A case study. [2022]
Mask interface for continuous positive airway pressure therapy: selection and design considerations. [2019]
Nurse practitioner-led, virtually delivered, motivational enhancement and device support intervention to improve CPAP adherence: A feasibility randomized control trial. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Simulated flying altitude and performance of continuous positive airway pressure devices. [2019]
11.United Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
Potential rebreathing after continuous positive airway pressure failure during sleep. [2019]