Clinical trial · Interventional
High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer
An Exploratory Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen for Persistent Dyspnea in Advanced Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIPAP | Device | — | UNRESOLVED |
| Vapotherm | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1: BiPAP then Vapotherm
- description
- Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
- interventionNames
- Device: Vapotherm
- Device: BIPAP
- type
- EXPERIMENTAL
- label
- Group 2: Vapotherm then BiPAP
- description
- Vapotherm air delivery then BiPAP.
- interventionNames
- Device: Vapotherm
- Device: BIPAP
Primary outcomes (2)
- measure
- Number of Participants Completing Study Intervention
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available