BiPAP-Vapotherm RCT
Novel Oxygen Delivery Modalities for Refractory Dyspnea in Patients With Advanced Cancer
1 other identifier
interventional
N/A
0 countries
N/A
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 shortness of breath.
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedAugust 13, 2013
August 1, 2013
6 years
January 23, 2012
August 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of 3 Different Oxygen Delivery Methods
Maximal inspiratory pressure measured at baseline, at end of the first hour, and after 4 hours of as-needed intervention using the NS 120-TRR negative inspiratory force monitor. Five consecutive efforts will be recorded, with a 1-minute pause between each effort (Ha-rik-Khan et al. 1998). Participants asked to rank the breathing devices based on their (1) efficacy in helping them to breathe, (2) comfort, and (3) ease of use on a numeric rating scale from 0 (best) to 10 (worst).
6 hours
Study Arms (3)
VapoTherm
EXPERIMENTALParticipants receive air through VapoTherm for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask.
BiPAP
EXPERIMENTALParticipants receive air through bilevel positive airway pressure (BiPAP) for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using non-rebreather mask.
Non-Rebreather Mask
EXPERIMENTALParticipants receive air through Non-Rebreather Mask for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using bilevel positive airway pressure (BiPAP).
Interventions
Participants receive air through VapoTherm for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask.
2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hui D, Morgado M, Chisholm G, Withers L, Nguyen Q, Finch C, Frisbee-Hume S, Bruera E. High-flow oxygen and bilevel positive airway pressure for persistent dyspnea in patients with advanced cancer: a phase II randomized trial. J Pain Symptom Manage. 2013 Oct;46(4):463-73. doi: 10.1016/j.jpainsymman.2012.10.284. Epub 2013 Jun 2.
PMID: 23739633DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Hui, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2012
First Posted
January 25, 2012
Study Start
December 1, 2013
Primary Completion
December 1, 2019
Last Updated
August 13, 2013
Record last verified: 2013-08