PEEP Mask for TBM-Induced Cough

Brief Title

PEEP Mask for Tracheobronchomalacia-Induced Cough

Official Title

Non-invasive Positive Expiratory Pressure Mask (PEEP-Mask) for Tracheobronchomalacia Associated Cough

Brief Summary

      This study aims to determine if an expiratory resistance device that delivers non-invasive
      positive expiratory pressure (nPEP) will reduce or stop coughing, reduce airway resistance
      and improve quality of life in patients with tracheobronchomalacia (TBM) who are not
      candidates for tracheal stenting.
    

Detailed Description

      PROSPECTIVE:

      Ten subjects with chronic cough and TBM diagnosed by bronchoscopy or computed tomography (CT)
      scan will be recruited. Comorbid conditions that can cause chronic cough, such as asthma,
      COPD, and GERD, must be treated if present, for subjects to qualify. At the pre-baseline
      visit (V-1), after obtaining written informed consent, each subject will complete validated
      cough questionnaires to quantify their cough severity and cough-related QOL at baseline. The
      baseline visit (V1) will occur approximately two weeks later, after a run-in period to
      minimize observation bias related to the cough questionnaires. At V1, the cough
      questionnaires will be repeated and subjects' airway resistance and reactance will be
      measured with impulse oscillometry (IOS). Subjects will then be given the nPEP device by the
      study team and instructed on its use. Approximately two weeks after device delivery, at the
      follow-up visit (V2), cough questionnaires and IOS will be repeated and they will be asked
      for feedback regarding device design and user experience. Subjects may then be entered into a
      cohort for up to six additional months, during which there will be no study visits or
      procedures, but subjects may be contacted by investigators for additional narrative feedback
      on the device and its use.

      Study subjects will be given an nPEP device to use for two weeks. During this time
      participants will be asked to remain on their current medical regimen and not to make any
      dose changes or add new drugs, unless indicated by their primary care provider. Impulse
      oscillometry will be measured at V1 and 2 weeks later at V2 to assess effect of the nPEP
      device on airway physiology.

      RETROSPECTIVE:

      This device was tried on two individuals and it was initiative and was beneficial. Many
      patients are not candidates for tracheobronchoplasty itself due to medical comorbidities,
      prefer to avoid the associated risks, or are not candidates for the required tracheal
      stenting due to trachea size or anatomy. These patients are left without a viable therapeutic
      option for their severe cough.

      Continuous positive airway pressure (CPAP) devices have been reported to stop or prevent
      cough in TBM, presumably through pneumatic stenting the large airways to maintain their
      patency during exhalation. CPAP devices, however, are not labeled for this indication and
      their functional utility is very limited given size of the device, need for a power source,
      and multiple steps to don the equipment that are not easily completed while actively and
      uncontrollably coughing.

      The physicians aimed to provide positive airway pressure at a low cost and through readily
      accessible means, in order to abort coughing paroxysms in patients who were not candidates
      for tracheal stenting and did not have access to commercial CPAP devices. Patients at Duke
      University Hospital referred to the Interventional Pulmonary service for evaluation of
      severe, debilitating TBM-related cough and possible tracheal stenting, but who were not
      candidates for tracheal stenting given their airway anatomy, were given positive end
      expiratory pressure (PEEP) masks assembled using existing hospital supplies. Specifically, a
      standard, adjustable (5-20 cm H2O) positive end expiratory pressure (PEEP) valve manufactured
      for attachment to a manual resuscitation (commonly known as bag-valve-mask) device was
      attached directly to a flexible face mask, also from a manual resuscitation device. Patients
      were instructed by their physicians how to use the PEEP masks. The patients used the PEEP
      mask immediately during their clinical encounter and were given a mask to take home. (The
      device was created by fellow, Lindsay Boole.)

      This was a limited intervention for a very small number of patients (two), specifically
      identified as being referred to Duke Interventional Pulmonary service with severe cough
      related to TBM, but with anatomy that ruled them out as candidates for tracheal stenting.
      There were no formal data collected and no separate follow-up for the purpose of this project
      (though patients had ongoing clinical follow-up per standard of care). The patients'
      subjective improvement with the masks was submitted as a case report abstract and poster at
      the American College of Chest Physician meeting in 2017.

      Other physicians asked Dr. Boole about the mask and if it could be used for their patients.
      Therefore, the investigators would like to request a retrospective review of all patients
      that used the PEEP mask between January 1, 2009 and August 20, 2019 to be included in this
      pilot study. Approximately 15 records will be reviewed.
    


Study Type

Interventional


Primary Outcome

Change in cough severity as measured by the Cough-Visual Analog Scale

Secondary Outcome

 Change in proximal airway resistance as assessed by impulse oscillometry

Condition

Tracheobronchomalacia

Intervention

nPEP (non-invasive positive expiratory pressure) mask

Study Arms / Comparison Groups

 nPEP Recipients
Description:  Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

January 30, 2021

Completion Date

July 1, 2021

Primary Completion Date

July 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 years

          -  Chronic cough for at least 8 weeks

          -  Visualization of ≥50% collapse of the trachea or mainstem bronchus on CT scan or
             bronchoscopy

          -  No upper or lower respiratory infection within 4 weeks

          -  Negative evaluation or treatment response for cough:

               -  Asthma (negative spirometry or treatment with oral corticosteroids or ≥moderate
                  dose of inhaled corticosteroids)

               -  Gastroesophageal reflux disease (GERD) (negative potential hydrogen (pH) probe or
                  treatment with proton pump inhibitor)

               -  Upper airway disease (nasal or oral corticosteroids, antihistamines)

               -  Chronic Obstructive Pulmonary Disease (COPD) (negative spirometry or treatment
                  with triple-inhaled therapy [≥moderate dose of inhaled corticosteroids,
                  long-acting muscarinic antagonist, and long-acting beta agonist])

          -  Having capacity to provide legal written informed consent

        Exclusion Criteria:

          -  History of tracheobronchoplasty or chronic tracheal stenting

          -  Current tracheostomy

          -  History of external chest trauma

          -  History of mediastinal goiter

          -  Current smoking within 6 months

          -  Current use of angiotensin-converting enzyme (ACE) inhibitor within 6 weeks

          -  Primary parenchymal lung disease

          -  History of:

               -  Sarcoidosis

               -  Interstitial lung disease

               -  Chronic mycobacterial infection

               -  Lung cancer

               -  Lung transplantation

               -  Unstable congestive heart failure

               -  History of spontaneous pneumothorax

          -  Other medical conditions that interfere with participation in the study
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Loretta G Que, MD, (919) 479-0861, [email protected]



Administrative Informations


NCT ID

NCT04169282

Organization ID

Pro00102498


Responsible Party

Sponsor

Study Sponsor

Duke University


Study Sponsor

Loretta G Que, MD, Principal Investigator, Duke University


Verification Date

October 2020