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

NCT03214458 | Completed FDA Device

• 1 other identifier: 24408
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Therapy; Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tolerance of HNHF-O2 measured by a 5-point Likert Scale

  3 days

• Tolerance of HNHF-O2 measured by a 100 mm visual analog scale

  3 days

Study Arms (1)

Nasal high flow with oxygen

OTHER

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

Interventions

Nasal high flow DEVICE

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

Nasal high flow with oxygen

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: July 11, 2017
• Study Start: July 20, 2017
• Primary Completion: April 16, 2018
• Study Completion: April 18, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)