Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic Obstructive Pulmonary Disease
Brief summary
The primary objective of this study is to look for a correlation between the use of high-flow nasal cannula in the outpatient setting in patients with previous chronic obstructive pulmonary disease exacerbation and the change in their Breathlessness, Cough, and Sputum Scale score. The hypothesis is that home use of high-flow nasal cannula will lead to a reduction in Breathlessness, Cough, and Sputum Scale score by 1.3.
Detailed description
This is a prospective pilot study. Targeted population include patients with chronic obstructive pulmonary disease , non-oxygen dependent, with a baseline normal bicarbonate on previous lab (within 6 months of enrollment). Patients will be randomly selected to be part of the study sample. Recruitment will occur in both inpatient and outpatient settings. An email briefly explaining the objectives of the study will be sent to Internal Medicine residents and Pulmonary Critical Care fellows to help in patients' recruitment. Patients will be enrolled in the study only after being seen by Dr. Abdo or Dr. Allen. The study is expected to finish by the end of January 2017 or twelve months post institutional review board approval. Patients will be recruited and enrolled over six months, and the collected data will be analyzed six months after the last patient was included in the study. The study will target a study sample of 30 as detailed in the statistical analysis section, where patients will be their own control (3 months without high-flow nasal cannula followed by 3 months with high-flow nasal cannula).
Interventions
DEVICEHigh-Flow Nasal Cannula
This is a humidified oxygen delivery system.
Sponsors
Fisher and Paykel Healthcare
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
One previous chronic obstructive pulmonary disease exacerbation in last year.
Exclusion criteria
Can not be oxygen dependant PaCO2 \< 60
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Breathlessness, Cough and Sputum Scale (BCSS) | 6 months | The Changes in Breathlessness, Cough and Sputum Scale (BCSS) is a three question measure consisting of three questions, each rated on a scale of 0 to 4, with a total possible score ranging from 0-12. Zero equals no difficulty and four equals severe difficulty or constant problem. A lower score on the scale is a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Chronic Obstructive Pulmonary Disease Exacerbations Per Month | 6 months | The number of chronic obstructive pulmonary disease exacerbations per month will be monitored throughout the study. A lower number of chronic obstructive pulmonary disease exacerbations are considered improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Flow Nasal Cannula Participants High Flow Nasal Cannula Participants will be their own control, they will be in study for 3 months prior to receiving equipment and then will be studied for 3 additional months on study.
High-Flow Nasal Cannula: This is a humidified oxygen delivery system. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | High Flow Nasal Cannula Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 6 participants | — |
| Sex/Gender, Customized Sex Not Collected | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Changes in Breathlessness, Cough and Sputum Scale (BCSS)
The Changes in Breathlessness, Cough and Sputum Scale (BCSS) is a three question measure consisting of three questions, each rated on a scale of 0 to 4, with a total possible score ranging from 0-12. Zero equals no difficulty and four equals severe difficulty or constant problem. A lower score on the scale is a better outcome.
Time frame: 6 months
Population: Four (4) participants were lost to follow-up and no data was collected. Two (2) participants returned BCSS scores at which time, baseline data was not collected due to decision to terminate study. Baseline data is required to calculate change in BCSS.
Secondary
Change in Number of Chronic Obstructive Pulmonary Disease Exacerbations Per Month
The number of chronic obstructive pulmonary disease exacerbations per month will be monitored throughout the study. A lower number of chronic obstructive pulmonary disease exacerbations are considered improvement.
Time frame: 6 months
Population: Four (4) participants were lost to follow-up and no data was collected on those participants. Data was not collected on remaining two (2) participants for this outcome measure.