Effects of Nasal High-flow Oxygen in Patients With an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Nasal high flow

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Nasal high flow with oxygen; 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.

Device: Nasal high flow; The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases/

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days
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"	3 days

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): April 16, 2018
• Study Completion (Actual): April 18, 2018

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Therapy; Noninvasive Ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 24408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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