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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Humidified nasal high flow with oxygen
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Therapy, Noninvasive Ventilation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Temple University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Nasal high flow with oxygen

Arm Description

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.

Outcomes

Primary Outcome Measures

Use of Oxygen Therapy by HNHF-O2 at Home
Number of hours of use of the device per day as recorded on the device

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2017
Last Updated
May 11, 2021
Sponsor
Temple University
Collaborators
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03221387
Brief Title
Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Fisher and Paykel Healthcare

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxia
Keywords
Therapy, Noninvasive Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal high flow with oxygen
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Humidified nasal high flow with oxygen
Other Intervention Name(s)
AIRVO 2
Intervention Description
The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.
Primary Outcome Measure Information:
Title
Use of Oxygen Therapy by HNHF-O2 at Home
Description
Number of hours of use of the device per day as recorded on the device
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Spirometry
Description
Change in FEV1
Time Frame
90 days
Title
Change in 6 Minute Walk Distance
Description
Total distance walked in 6 minutes
Time Frame
90 days
Title
Breathlessness
Description
Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Sputum Quantity
Description
Volume of sputum
Time Frame
Measured daily for 90 days
Title
Sputum Consistency
Description
Watery, thin, thick, none, no report made
Time Frame
Measured daily for 90 days
Title
Sputum Color
Description
Clear, yellow, brown, white, none
Time Frame
Measured daily for 90 days
Title
Peak Flow
Description
liters/minute
Time Frame
Measured daily for 90 days
Title
Body Temperature > 100 Degrees F
Description
Yes/no Subjects recorded body temperature via thermometer
Time Frame
Measured daily for 90 days
Title
Presence of Cough
Description
Yes/no
Time Frame
Measured daily for 90 days
Title
Presence of Wheeze
Description
Yes/no
Time Frame
Measured daily for 90 days
Title
Presence of Sore Throat
Description
Yes/no
Time Frame
Measured daily for 90 days
Title
Presence of Nasal Congestion
Description
Yes/no
Time Frame
Measured daily for 90 days
Title
Polysomnography
Description
Heart rate
Time Frame
70 days
Title
Polysomnography
Description
Pulse oximetry
Time Frame
70 days
Title
Polysomnography
Description
Total sleep time in hours
Time Frame
70 days
Title
Polysomnography
Description
Sleep efficiency (percent of time sleeping/total amount of time in bed)
Time Frame
70 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard J Criner, MD
Organizational Affiliation
Temple University Lewis Katz School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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