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HFNC Effect on BCSS in Patients With COPD (COPD)

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ClinicalTrials.gov Identifier: NCT02825043
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Karen Allen, University of Oklahoma

Brief Summary:
The primary objective of this study is to look for a correlation between the use of HFNC in the outpatient setting in patients with previous COPD exacerbation and the change in their BCSS score. The hypothesis is that home use of HFNC will lead to a reduction in BCSS 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 COPD, 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 IRB 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 HFNC followed by 3 months with HFNC).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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)
Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

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. Decreased breathlessness, cough and sputum score. [ Time Frame: 6 months ]
    Patients will measure score weekly and use high flow to try to decrease score/improve symptoms.


Secondary Outcome Measures :
  1. Decrease COPD exacerbations. [ Time Frame: 6 months ]
    Monitor COPD exacerbations.



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 COPD 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


Contacts
Contact: Karen Allen, MD 405-271-6173 karen-allen@ouhsc.edu
Contact: Tony Abdo, MD 405-271-6173 Tony-Abdo@ouhsc.edu

Locations
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Karen Allen, MD    405-271-1673    karen-allen@ouhsc.edu   
Contact: Tony Abdo, MD    405-271-1673    tony-abdo@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Fisher and Paykel Healthcare
Investigators
Principal Investigator: Karen Allen, MD OUMC

Publications:

Responsible Party: Karen Allen, Faculty, University of Oklahoma
ClinicalTrials.gov Identifier: NCT02825043     History of Changes
Other Study ID Numbers: 6410
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
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 Karen Allen, University of Oklahoma:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases