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Clinical Trials/NCT02825043
NCT02825043
Terminated
Not Applicable

Effect of High-Flow Nasal Cannula (HFNC) on the Breathlessness, Cough, and Sputum Scale (BCSS), in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)

University of Oklahoma1 site in 1 country6 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
University of Oklahoma
Enrollment
6
Locations
1
Primary Endpoint
Changes in Breathlessness, Cough and Sputum Scale (BCSS)
Status
Terminated
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
November 21, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • One previous chronic obstructive pulmonary disease exacerbation in last year.

Exclusion Criteria

  • Can not be oxygen dependant PaCO2 \< 60

Outcomes

Primary Outcomes

Changes in Breathlessness, Cough and Sputum Scale (BCSS)

Time Frame: 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 Outcomes

  • Change in Number of Chronic Obstructive Pulmonary Disease Exacerbations Per Month(6 months)

Study Sites (1)

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