Effects of Nasal High-flow Oxygen in Patients With an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal high flow
Sponsored by
About this trial
This is an interventional device feasibility trial for Chronic Obstructive Pulmonary Disease focused on measuring Therapy, Noninvasive Ventilation
Eligibility Criteria
Inclusion Criteria:
- Males and females 40 years of age or older
- Hospitalized for an acute exacerbation of COPD on the 6th floor of Rock Pavilion (pulmonary inpatient service)
- Smoking history of > 10 pack-years
- PaCO2 ≥ 45 mm Hg
- Able to provide informed consent
- Willing to participate in daily measurements of arterial blood gases, completion of study questionnaires, and other study-related procedures
Exclusion Criteria:
- Upper airway or nasal problems that prohibit the use of humidified high-flow nasal oxygen
- Hemodynamic instability defined as the need for blood pressure or blood volume support to maintain adequate tissue perfusion and oxygenation
- Urgent need for endotracheal intubation
- A do-not-intubate order
- A known diagnosis of obstructive sleep apnea
- Present use of continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) therapy
Sites / Locations
- Temple University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nasal high flow with oxygen
Arm Description
During HFNC-oxygen, oxygen will be passed through a heated humidifier (AIRVO-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs (Optiflow+ Fisher and Paykel Healthcare), with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep Arterial oxygen saturation (SaO2) > 90%. Temperature will be adjusted based on patient's comfort and range from 34-37 degrees based on prior experience.
Outcomes
Primary Outcome Measures
Ability to maintain oxygen saturation at or above 90%
The need to intensify therapy because HNHF-O2 does not achieve the targeted oxygen saturation of ≥ 90% resulting in the need to intensify respiratory support
Secondary Outcome Measures
Tolerance of HNHF-O2 measured by a 5-point Likert Scale
Likert scale model indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2) in patient's sensation of shortness of breath.
Tolerance of HNHF-O2 measured by a 100 mm visual analog scale
Discomfort assessed using an unmarked 100 mm visual analogic scale from "no discomfort" to "maximal imaginable discomfort"
Full Information
NCT ID
NCT03214458
First Posted
June 19, 2017
Last Updated
April 18, 2018
Sponsor
Temple University
Collaborators
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03214458
Brief Title
Effects of Nasal High-flow Oxygen in Patients With an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Tolerance and Acute Effects of Humidified Nasal High-flow With Oxygen (HNHF-O2) on Gas Exchange in Patients Hospitalized With an Acute Exacerbation of COPD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Fisher and Paykel Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are looking at the effect of humidified nasal high-flow with oxygen (HNHF-O2) on air exchange during exacerbations of COPD. HNHF-O2 therapy may have beneficial effects in patients with severe breathing impairment that results in low oxygen in the blood. Some studies show that patients with low blood oxygen levels who use HFNC oxygen have lower rates of needing mechanical ventilation.
Detailed Description
Patients admitted to the hospital with an exacerbation of COPD accompanied by respiratory failure need supplemental oxygen and alleviation of an increased work of breathing. Patients with acute exacerbations of COPD have hypoxemia, hypercapnia and an elevated work of breathing due to increased airways obstruction and hyperinflation. Patient outcomes can be improved by aggressive bronchodilation and systemic corticosteroids, but methods that can augment spontaneous ventilation and decrease the work of breathing can help avoid intubation. High flow nasal cannula (HFNC) has been shown to be useful in patients with severe hypoxemic respiratory failure and those recently extubated from mechanical ventilation. HFNC provides warmed and humidified high flow (10-60L/min) by nasal cannula that allows precise titration of % inspired FiO2 in the air/oxygen blend. The AIRVO 2 device delivers warmed and humidified respiratory gases to spontaneously breathing patients using a humidifier and integrated flow generator. In this study, the air/ oxygen gas blend (20-35L/min) will be administered by the AIRVO 2 HNHF device to achieve an fraction of inspired oxygen (FiO2) > 90% at rest. A potential advantage of the AIRVO 2 HNHF device includes the ability of the device to deliver oxygen that has been warmed and humidified. Also, the high flow rates achieved with this device may reduce the work of breathing. This is an open-labeled pilot study of ten patients to determine the safety and feasibility of using the device in the management of patients with an acute exacerbation of COPD with acute on chronic respiratory failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Therapy, Noninvasive Ventilation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal high flow with oxygen
Arm Type
Other
Arm Description
During HFNC-oxygen, oxygen will be passed through a heated humidifier (AIRVO-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs (Optiflow+ Fisher and Paykel Healthcare), with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep Arterial oxygen saturation (SaO2) > 90%. Temperature will be adjusted based on patient's comfort and range from 34-37 degrees based on prior experience.
Intervention Type
Device
Intervention Name(s)
Nasal high flow
Intervention Description
The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases/
Primary Outcome Measure Information:
Title
Ability to maintain oxygen saturation at or above 90%
Description
The need to intensify therapy because HNHF-O2 does not achieve the targeted oxygen saturation of ≥ 90% resulting in the need to intensify respiratory support
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Tolerance of HNHF-O2 measured by a 5-point Likert Scale
Description
Likert scale model indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2) in patient's sensation of shortness of breath.
Time Frame
3 days
Title
Tolerance of HNHF-O2 measured by a 100 mm visual analog scale
Description
Discomfort assessed using an unmarked 100 mm visual analogic scale from "no discomfort" to "maximal imaginable discomfort"
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females 40 years of age or older
Hospitalized for an acute exacerbation of COPD on the 6th floor of Rock Pavilion (pulmonary inpatient service)
Smoking history of > 10 pack-years
PaCO2 ≥ 45 mm Hg
Able to provide informed consent
Willing to participate in daily measurements of arterial blood gases, completion of study questionnaires, and other study-related procedures
Exclusion Criteria:
Upper airway or nasal problems that prohibit the use of humidified high-flow nasal oxygen
Hemodynamic instability defined as the need for blood pressure or blood volume support to maintain adequate tissue perfusion and oxygenation
Urgent need for endotracheal intubation
A do-not-intubate order
A known diagnosis of obstructive sleep apnea
Present use of continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) therapy
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Nasal High-flow Oxygen in Patients With an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
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