HFNC Effect on BCSS in Patients With COPD (COPD)

June 12, 2020 updated by: University of Oklahoma

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

One previous chronic obstructive pulmonary disease exacerbation in last year.

Exclusion Criteria:

Can not be oxygen dependant PaCO2 < 60

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • AIRVO 2 Series Humidifier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Karen Allen, MD, OUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

November 21, 2018

Study Completion (ACTUAL)

November 21, 2018

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (ESTIMATE)

July 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will share data as a cohort for other investigators, but will not share individual participant data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on High-Flow Nasal Cannula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe