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BiPAP-Vapotherm RCT

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01518140
First received: January 23, 2012
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Advanced Cancers
Device: Oxygen Delivery Devices
Behavioral: Questionnaires
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Novel Oxygen Delivery Modalities for Refractory Dyspnea in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Efficacy of 3 Different Oxygen Delivery Methods [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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).


Enrollment: 0
Study Start Date: December 2013
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VapoTherm
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.
Device: Oxygen Delivery Devices
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.
Behavioral: Questionnaires
2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete.
Other Name: Surveys
Experimental: BiPAP
Participants 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.
Device: Oxygen Delivery Devices
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.
Behavioral: Questionnaires
2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete.
Other Name: Surveys
Experimental: Non-Rebreather Mask
Participants 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).
Device: Oxygen Delivery Devices
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.
Behavioral: Questionnaires
2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete.
Other Name: Surveys

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of advanced cancer, defined as locally advanced, recurrent, or metastatic disease
  2. 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
  3. Dyspnea judged clinically to be predominantly due to the underlying malignancy, with or without obstructive lung disease
  4. Inpatient at MD Anderson Cancer Center
  5. Able to communicate in English
  6. Expected life expectancy >1 week
  7. Age 18 or older

Exclusion Criteria:

  1. Hypoxia (i.e., O2 saturation <90%) despite supplemental oxygen at 15 L/min
  2. Hemodynamic instability (systemic blood pressure (SBP) <90 mmHg) within 1 hour of study initiation
  3. Comatose state or delirium, as indicated by a Memorial Delirium Assessment Scale score of 13 or higher
  4. Uncontrolled arrhythmia as per clinical record at enrollment
  5. Upper GI bleeding within 2 weeks of enrollment
  6. Esophageal rupture at enrollment
  7. Upper airway obstruction at enrollment
  8. History of facial trauma within 2 weeks of enrollment
  9. Facial, upper airway, or GI surgery within 2 weeks of enrollment
  10. Thoracic surgery within 6 weeks of enrollment
  11. Excessive airway secretions interfering with BiPAP administration
  12. Undrained pneumothorax at enrollment
  13. Partial or complete small bowel obstruction or severe nausea/vomiting (Edmonton symptom assessment scale nausea >7/10) within 48 hours of enrollment
  14. Hemoglobin <8 g/dL at the time of enrollment (blood drawn within past 2 weeks)
  15. Acute exacerbation of chronic obstructive pulmonary disease (COPD) or heart failure within 1 week of enrollment by history or physical
  16. Known CO2 retainers as per clinic station
  17. Known pulmonary hypertension as per clinic station
  18. Unwillingness to provide consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518140

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: David Hui, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01518140     History of Changes
Other Study ID Numbers: 2011-0689
Study First Received: January 23, 2012
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Locally advanced
Recurrent
Metastatic disease
Oxygen Delivery Modalities
Shortness of breath
Dyspnea
VapoTherm
Bilevel positive airway pressure
BiPAP
Non-rebreather mask

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014