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HFNC Effect on BCSS in Patients With COPD (COPD)

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ClinicalTrials.gov Identifier: NCT02825043
Recruitment Status : Terminated (Slow enrollment and unable to meet enrollment targets)
First Posted : July 7, 2016
Results First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: High-Flow Nasal Cannula Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of High-Flow Nasal Cannula (HFNC) on the Breathlessness, Cough, and Sputum Scale (BCSS), in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : February 2016
Actual Primary Completion Date : November 21, 2018
Actual Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: High-Flow Nasal Cannula
This is a humidified oxygen delivery system.
Other Name: AIRVO 2 Series Humidifier




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Number of Chronic Obstructive Pulmonary Disease Exacerbations Per Month [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

One previous chronic obstructive pulmonary disease exacerbation in last year.

Exclusion Criteria:

Can not be oxygen dependant PaCO2 < 60


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825043


Locations
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United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Karen Allen, MD OUMC
  Study Documents (Full-Text)

Documents provided by University of Oklahoma:
Publications:

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT02825043    
Other Study ID Numbers: 6410
First Posted: July 7, 2016    Key Record Dates
Results First Posted: June 29, 2020
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will share data as a cohort for other investigators, but will not share individual participant data.
Keywords provided by University of Oklahoma:
Chronic Obstructive Pulmonary Disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases