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

Feasibility of Using Daily Home HNHF-O2 During Sleep and/or Daytime in Hypercapnic COPD Patients Following Recent (&lt 12 Wks.) Hospitalization for AECOPD for 90 Days

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Pulmonary Disease, Chronic Obstructive; Hypercapnia
• Intervention / Treatment: Device: Humidified nasal high flow with oxygen

Detailed Description

Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure. HNHF-O2 may be beneficial in patients with COPD and chronic impairments in gas exchange, both hypoxemia as well as hypercapnia. HNHF-O2 may decrease work of breathing, reduce dyspnea, improve airway humidification, and potentially stabilize or reduce carbon dioxide levels. However, there is limited data showing the chronic effects of HNHF-O2 in patients with hypercapnic respiratory failure, specifically those discharged to home following hospitalization for an acute exacerbation. Data that demonstrates that HNHF-O2 is well tolerated, and stabilizes or improves gas exchange long term in patients with COPD is lacking. Similarly, data that demonstrates that this therapeutic regimen is feasible to provide to patients in the home environment are lacking. This is an open-labeled pilot study of thirty patients to determine the safety and feasibility of using the device in the outpatient management of patients with COPD. A subset of ten patients will have serial sleep studies to determine the effects, if any, on sleep.

• Study Type: Interventional
• Enrollment (Actual): 30
• 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:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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; 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; The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.; Other Names: AIRVO 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry	Change in FEV1	90 days
Change in 6 Minute Walk Distance	Total distance walked in 6 minutes	90 days
Breathlessness	Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sputum Quantity	Volume of sputum	Measured daily for 90 days
Sputum Consistency	Watery, thin, thick, none, no report made	Measured daily for 90 days
Sputum Color	Clear, yellow, brown, white, none	Measured daily for 90 days
Peak Flow	liters/minute	Measured daily for 90 days
Body Temperature > 100 Degrees F	Yes/no Subjects recorded body temperature via thermometer	Measured daily for 90 days
Presence of Cough	Yes/no	Measured daily for 90 days
Presence of Wheeze	Yes/no	Measured daily for 90 days
Presence of Sore Throat	Yes/no	Measured daily for 90 days
Presence of Nasal Congestion	Yes/no	Measured daily for 90 days
Polysomnography	Heart rate	70 days
Polysomnography	Pulse oximetry	70 days
Polysomnography	Total sleep time in hours	70 days
Polysomnography	Sleep efficiency (percent of time sleeping/total amount of time in bed)	70 days

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Gerard J Criner, MD, Temple University Lewis Katz School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2017
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Therapy; Noninvasive Ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoxia; Hypercapnia
• Other Study ID Numbers: 24406

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