High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer
Condition: Advanced Cancers
MeSH terms: Neoplasms; Dyspnea
Intervention: Vapotherm; BIPAP
Intervention description: Deliver air in and out of the lungs, warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.; Air given through a mask, and amount can be set to different levels allowing more air in and out of lungs without using as much effort as regular breathing.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancer; Persistent Dyspnea; Shortness of breath; Specialized breathing devices; Bilevel positive airway pressure device; BIPAP; High flow oxygen delivery device; VapoTherm; Edmonton Symptom Assessment Scale; ESAS

Summary:

      The goal of this clinical research study is to learn if specialized breathing devices reduce
      the sensation of shortness of breath in patients with advanced cancer who are experiencing
      shortness of breath. Researchers want to learn if these devices can help to control shortness
      of breath.

      The 2 devices being tested and compared are called BiPAP (bilevel positive airway pressure)
      and Vapotherm.
    

Eligibility criteria:

        Inclusion Criteria:

          1. History of advanced cancer, defined as locally advanced, recurrent or metastatic
             disease

          2. Patients with persistent dyspnea, defined in this study as dyspnea at rest with an
             average intensity level >/=3 out of a Numeric Rating Scale from 0 to 10 for at least 2
             week and just prior to study initiation, despite supplemental oxygen of up to 21 L/min
             to keep oxygen saturation >/=90%

          3. Dyspnea is judged clinical to be predominantly due to underlying malignancy, with or
             without obstructive lung disease

          4. Inpatient at MD Anderson Cancer Center

          5. Patients with cancer treatment related dyspnea are eligible for this study if they
             meet the eligibility criteria above.

          6. Able to communicate in English

          7. Expected life expectancy >1 week

          8. Patients with a diagnosis of pneumonia are also eligible for this study if they meet
             the eligibility criteria above, with dyspnea >=2 weeks prior to the diagnosis of
             pneumonia.

          9. Age 18 or greater

        Exclusion Criteria:

          1. Patients who remain hypoxic (i.e. O2 saturation <90% despite maximal oxygen delivery
             (21 L/min) are not included in this study because they are considered to have severe
             life-threatening respiratory failure and are too unstable for study inclusion.

          2. Hemodynamic instability (Heart Rate (HR) >140, systolic blood pressure (SBP) <80)
             within 24 hours of study initiation (as per Clinic Station)

          3. Acute respiratory distress requiring intubation

          4. Delirium as indicated by a Memorial Delirium Assessment Scale (MDAS) of 13 or higher

          5. Glasglow coma scale <8

          6. Excessive airway secretions interfering with BIPAP administration

          7. History of facial trauma within 1 month of enrollment

          8. Upper GI bleed within 2 weeks of enrollment or esophageal rupture

          9. Partial or complete small bowel obstruction or severe nausea/vomiting (ESAS nausea
             >7/10) within 48 hours of enrollment

         10. Hemoglobin <8 g/dL at the time of enrollment (blood draw within last 2 weeks)

         11. Acute exacerbation of COPD or CHF within 2 weeks of enrollment by history or physical

         12. Unwilling to provide informed consent

         13. Diagnosis of non-cancer related dyspnea (e.g. Chronic obstructive pulmonary disease
             (COPD), congestive heart failure (CHF) or any chronic respiratory disease) requiring
             supplemental home oxygen prior to hospitalization.