Status:
WITHDRAWN
BiPAP-Vapotherm RCT
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if 3 breathing devices reduce feeling short of breath in cancer patients. Researchers also want to learn if these devices can help to control short...
Detailed Description
Device A is designed to get more air in and out of their lungs without using as much effort as regular breathing. The air is given through a mask, and the amount of air can be set to different levels....
Eligibility Criteria
Inclusion
- Diagnosis of advanced cancer, defined as locally advanced, recurrent, or metastatic disease
- Persistent dyspnea, defined in this study as dyspnea at rest with an average intensity level \>=3/10 on the numeric rating scale for at least 1 week and just prior to study initiation despite supplemental oxygen for at least 30 minutes
- Dyspnea judged clinically to be predominantly due to the underlying malignancy, with or without obstructive lung disease
- Inpatient at MD Anderson Cancer Center
- Able to communicate in English
- Expected life expectancy \>1 week
- Age 18 or older
Exclusion
- Hypoxia (i.e., O2 saturation \<90%) despite supplemental oxygen at 15 L/min
- Hemodynamic instability (systemic blood pressure (SBP) \<90 mmHg) within 1 hour of study initiation
- Comatose state or delirium, as indicated by a Memorial Delirium Assessment Scale score of 13 or higher
- Uncontrolled arrhythmia as per clinical record at enrollment
- Upper GI bleeding within 2 weeks of enrollment
- Esophageal rupture at enrollment
- Upper airway obstruction at enrollment
- History of facial trauma within 2 weeks of enrollment
- Facial, upper airway, or GI surgery within 2 weeks of enrollment
- Thoracic surgery within 6 weeks of enrollment
- Excessive airway secretions interfering with BiPAP administration
- Undrained pneumothorax at enrollment
- Partial or complete small bowel obstruction or severe nausea/vomiting (Edmonton symptom assessment scale nausea \>7/10) within 48 hours of enrollment
- Hemoglobin \<8 g/dL at the time of enrollment (blood drawn within past 2 weeks)
- Acute exacerbation of chronic obstructive pulmonary disease (COPD) or heart failure within 1 week of enrollment by history or physical
- Known CO2 retainers as per clinic station
- Known pulmonary hypertension as per clinic station
- Unwillingness to provide consent
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01518140
Start Date
December 1 2013
Last Update
August 13 2013
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