High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer, Cancer, Pulmonary |
Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/28/2018 |
Start Date: | October 11, 2016 |
End Date: | October 2019 |
The goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen,
high-flow air, and low-flow air in helping to decrease shortness of breath in cancer
patients. Researchers also want to learn if these therapies can help to improve lung function
and quality of life.
high-flow air, and low-flow air in helping to decrease shortness of breath in cancer
patients. Researchers also want to learn if these therapies can help to improve lung function
and quality of life.
Study Groups and Procedures:
If you agree to take part in this study, you will receive 4 different breathing therapies:
- High-flow oxygen
- Low-flow oxygen
- High-flow air and
- Low-flow air
The order in which they will be given to you will be randomly assigned (as in a roll of
dice). You will have an equal chance of being assigned to each group. Neither you nor the
study staff will know which therapy order you are assigned to. However, if needed for your
safety, the study staff will be able to find out what you are receiving.
All 4 breathing therapies should take about 80 minutes total to complete (10 minutes for each
treatment with a 10 minute break between each treatment). You will receive the air or oxygen
through small tubes placed in your nose. The respiratory therapist will be there to adjust
the therapy to your comfort level.
At the end of each breathing therapy, you will be asked about your shortness of breath and if
you have any improvement. You will also be asked if you could tell whether you received
oxygen or air after each therapy.
After finishing the 4 breathing therapies, you will complete 2 questionnaires about which
breathing therapy you liked and your thoughts about taking part in the study. These should
take about 10 minutes total to complete.
Length of Study:
You will be taken off study if you no longer wish to take part, or if you need drugs to help
with shortness of breath during the study. Your participation in the study will be over after
you complete the questionnaires.
This is an investigational study. Comparing high-flow air, low-flow air, high-flow oxygen,
and low-flow oxygen to treat shortness of breath is considered investigational.
Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.
If you agree to take part in this study, you will receive 4 different breathing therapies:
- High-flow oxygen
- Low-flow oxygen
- High-flow air and
- Low-flow air
The order in which they will be given to you will be randomly assigned (as in a roll of
dice). You will have an equal chance of being assigned to each group. Neither you nor the
study staff will know which therapy order you are assigned to. However, if needed for your
safety, the study staff will be able to find out what you are receiving.
All 4 breathing therapies should take about 80 minutes total to complete (10 minutes for each
treatment with a 10 minute break between each treatment). You will receive the air or oxygen
through small tubes placed in your nose. The respiratory therapist will be there to adjust
the therapy to your comfort level.
At the end of each breathing therapy, you will be asked about your shortness of breath and if
you have any improvement. You will also be asked if you could tell whether you received
oxygen or air after each therapy.
After finishing the 4 breathing therapies, you will complete 2 questionnaires about which
breathing therapy you liked and your thoughts about taking part in the study. These should
take about 10 minutes total to complete.
Length of Study:
You will be taken off study if you no longer wish to take part, or if you need drugs to help
with shortness of breath during the study. Your participation in the study will be over after
you complete the questionnaires.
This is an investigational study. Comparing high-flow air, low-flow air, high-flow oxygen,
and low-flow oxygen to treat shortness of breath is considered investigational.
Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.
Inclusion Criteria:
1. Diagnosis of cancer
2. Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency
care at MD Anderson Cancer Center
3. Dyspnea Numeric Rating Scale at rest >/=3 of 10 (average over last 24 hour)
4. Non-hypoxemic (i.e. oxygen saturation >90% on ambient air)
5. Able to communicate in English or Spanish
6. Age >/= 18 years
7. Able to tolerate high-flow oxygen/air
Exclusion Criteria:
1. Memorial Delirium Rating Scale >13
2. Hemodynamic instability
3. Respiratory failure requiring mechanical ventilation or non-invasive ventilation
4. Frequent use of rescue opioids >8x/day or rescue bronchodilators >8x/day over last 24
hours
5. Currently requiring high flow oxygen for oxygenation
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Phone: 713-792-6085
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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