Status:
COMPLETED
High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer
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 specialized breathing devices reduce the sensation of shortness of breath in patients with advanced cancer who are experiencing shortness of bre...
Detailed Description
Study Devices: The BiPAP device is designed to help people 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...
Eligibility Criteria
Inclusion
- History of advanced cancer, defined as locally advanced, recurrent or metastatic disease
- 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%
- Dyspnea is judged clinical to be predominantly due to underlying malignancy, with or without obstructive lung disease
- Inpatient at MD Anderson Cancer Center
- Patients with cancer treatment related dyspnea are eligible for this study if they meet the eligibility criteria above.
- Able to communicate in English
- Expected life expectancy \>1 week
- 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.
- Age 18 or greater
Exclusion
- 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.
- Hemodynamic instability (Heart Rate (HR) \>140, systolic blood pressure (SBP) \<80) within 24 hours of study initiation (as per Clinic Station)
- Acute respiratory distress requiring intubation
- Delirium as indicated by a Memorial Delirium Assessment Scale (MDAS) of 13 or higher
- Glasglow coma scale \<8
- Excessive airway secretions interfering with BIPAP administration
- History of facial trauma within 1 month of enrollment
- Upper GI bleed within 2 weeks of enrollment or esophageal rupture
- Partial or complete small bowel obstruction or severe nausea/vomiting (ESAS nausea \>7/10) within 48 hours of enrollment
- Hemoglobin \<8 g/dL at the time of enrollment (blood draw within last 2 weeks)
- Acute exacerbation of COPD or CHF within 2 weeks of enrollment by history or physical
- Unwilling to provide informed consent
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00934128
Start Date
August 1 2009
End Date
November 1 2012
Last Update
March 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030