Trial Outcomes & Findings for Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients (NCT NCT03221387)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

90 days

Results posted on

2021-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.
Overall Study Lost to Follow-up	1
Overall Study Lung transplant	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nasal High Flow With Oxygen n=28 Participants 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. 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.
Age, Continuous Age	69.2 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
GOLD grade at enrollment GOLD 2	1 participants n=5 Participants
GOLD grade at enrollment GOLD 3	12 participants n=5 Participants
GOLD grade at enrollment GOLD 4	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

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

Outcome measures

Outcome measures
Measure	Nasal High Flow With Oxygen n=28 Participants 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. 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.
Use of Oxygen Therapy by HNHF-O2 at Home	6.8 Hours Standard Deviation 2.1

SECONDARY outcome

Timeframe: 90 days

Change in FEV1

Outcome measures

Outcome measures
Measure	Nasal High Flow With Oxygen n=28 Participants 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. 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.
Spirometry	0.07 Liters Standard Deviation 0.6

SECONDARY outcome

Timeframe: 90 days

Total distance walked in 6 minutes

Outcome measures

Outcome measures
Measure	Nasal High Flow With Oxygen n=28 Participants 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. 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.
Change in 6 Minute Walk Distance	18.8 meters Standard Error 13.6

SECONDARY outcome

Timeframe: 90 days

Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath