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HFNC Effect on BCSS in Patients With COPD

Not Applicable
Terminated
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Device: High-Flow Nasal Cannula
Registration Number
NCT02825043
Lead Sponsor
University of Oklahoma
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).

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
6
Inclusion Criteria

One previous chronic obstructive pulmonary disease exacerbation in last year.

Exclusion Criteria

Can not be oxygen dependant PaCO2 < 60

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
High Flow Nasal Cannula ParticipantsHigh-Flow Nasal CannulaHigh 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.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Change in Number of Chronic Obstructive Pulmonary Disease Exacerbations Per Month6 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.

Trial Locations

Locations (1)

University of Oklahoma

🇺🇸

Oklahoma City, Oklahoma, United States

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