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HFNC Effect on BCSS in Patients With COPD (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Flow Nasal Cannula
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

One previous chronic obstructive pulmonary disease exacerbation in last year.

Exclusion Criteria:

Can not be oxygen dependant PaCO2 < 60

Sites / Locations

  • University of Oklahoma

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High Flow Nasal Cannula Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 29, 2016
Last Updated
June 12, 2020
Sponsor
University of Oklahoma
Collaborators
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02825043
Brief Title
HFNC Effect on BCSS in Patients With COPD
Acronym
COPD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment and unable to meet enrollment targets
Study Start Date
February 2016 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Cannula Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High-Flow Nasal Cannula
Other Intervention Name(s)
AIRVO 2 Series Humidifier
Intervention Description
This is a humidified oxygen delivery system.
Primary Outcome Measure Information:
Title
Changes in Breathlessness, Cough and Sputum Scale (BCSS)
Description
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
Secondary Outcome Measure Information:
Title
Change in Number of Chronic Obstructive Pulmonary Disease Exacerbations Per Month
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: One previous chronic obstructive pulmonary disease exacerbation in last year. Exclusion Criteria: Can not be oxygen dependant PaCO2 < 60
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Allen, MD
Organizational Affiliation
OUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Will share data as a cohort for other investigators, but will not share individual participant data.
Citations:
PubMed Identifier
25742321
Citation
Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.
Results Reference
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PubMed Identifier
25866645
Citation
Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
Results Reference
background
PubMed Identifier
25981908
Citation
Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
Results Reference
background
PubMed Identifier
26339486
Citation
Braunlich J, Seyfarth HJ, Wirtz H. Nasal High-flow versus non-invasive ventilation in stable hypercapnic COPD: a preliminary report. Multidiscip Respir Med. 2015 Sep 3;10(1):27. doi: 10.1186/s40248-015-0019-y. eCollection 2015.
Results Reference
background
PubMed Identifier
23128844
Citation
Braunlich J, Beyer D, Mai D, Hammerschmidt S, Seyfarth HJ, Wirtz H. Effects of nasal high flow on ventilation in volunteers, COPD and idiopathic pulmonary fibrosis patients. Respiration. 2013;85(4):319-25. doi: 10.1159/000342027. Epub 2012 Nov 1.
Results Reference
background
PubMed Identifier
22826046
Citation
Nilius G, Franke KJ, Domanski U, Ruhle KH, Kirkness JP, Schneider H. Effects of nasal insufflation on arterial gas exchange and breathing pattern in patients with chronic obstructive pulmonary disease and hypercapnic respiratory failure. Adv Exp Med Biol. 2013;755:27-34. doi: 10.1007/978-94-007-4546-9_4.
Results Reference
background
PubMed Identifier
14665499
Citation
Leidy NK, Rennard SI, Schmier J, Jones MK, Goldman M. The breathlessness, cough, and sputum scale: the development of empirically based guidelines for interpretation. Chest. 2003 Dec;124(6):2182-91. doi: 10.1378/chest.124.6.2182.
Results Reference
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HFNC Effect on BCSS in Patients With COPD

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