Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients

NCT03221387 | Completed Results FDA Device

• 1 other identifier: 24406
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure who have been hospitalized. The usefulness of this therapy in the outpatient setting is unproven. This pilot study will test the feasibility of using this therapy in the outpatient setting and its effects on sleep.

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia; Hypoxia

Keywords

Therapy; Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Use of Oxygen Therapy by HNHF-O2 at Home

  Number of hours of use of the device per day as recorded on the device

  90 days

Secondary Outcomes (3)

• Spirometry

  90 days

• Change in 6 Minute Walk Distance

  90 days

• Breathlessness

  90 days

Other Outcomes (13)

• Sputum Quantity

  Measured daily for 90 days

• Sputum Consistency

  Measured daily for 90 days

• Sputum Color

  Measured daily for 90 days

Study Arms (1)

Nasal high flow with oxygen

OTHER

While in the clinic High Flow Nasal Cannula 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. The subject will be discharged to home and instructed to use the high flow nasal cannula system at night and during the daytime while at home and resting.

Device: Humidified nasal high flow with oxygen

Interventions

Humidified nasal high flow with oxygen DEVICE

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

Also known as: AIRVO 2

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:

• admitted to the hospital for an acute exacerbation of COPD within the past 12 weeks
• have COPD as the primary diagnosis
• have smoked \> 10 pack years.
• receiving supplemental oxygen as part of their usual clinical care.
• willing to give informed consent

You may not qualify if:

• upper airway or nasal problems that prohibit the use of high flow oxygen
• current use (≤ 4 weeks of study entry) of any PAP-therapy (e.g., CPAP or NPPV)
• sleep apnea as follows: STOPBang scores ≥ 5 or STOPBang score ≥ 2 plus BMI \> 35 kg/m2; or Berlin questionnaire scores suggesting high likelihood of sleep apnea with increased risk of sleep-related accident (e.g., occupation as a commercial driver or pilot);
• excessive daytime sleepiness (i.e., either of High (\>15) score on the Epworth Sleepiness Scale or "fall asleep" accident or "near miss" accident in prior 12 months).

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; Hypercapnia; Hypoxia

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Limitations and Caveats

Single center study; no active control group; feasibility study

Results Point of Contact

• Title: Adam Nester, JD, MS
• Organization: Lewis Katz School of Medicine at Temple University

coisom@temple.edu

215-707-1986

Study Officials

• Gerard J Criner, MD

  Temple University Lewis Katz School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 18, 2017
• Study Start: September 10, 2017
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: June 7, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)