Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
NCT Number: NCT03221387
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.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19140, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 90 days
Number of hours of use of the device per day as recorded on the device
Time frame: 90 days
Change in FEV1
Time frame: 90 days
Total distance walked in 6 minutes
Time frame: 90 days
Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath
Time frame: Measured daily for 90 days
Volume of sputum
Time frame: Measured daily for 90 days
Watery, thin, thick, none, no report made
Time frame: Measured daily for 90 days
Clear, yellow, brown, white, none
Time frame: Measured daily for 90 days
liters/minute
Time frame: Measured daily for 90 days
Yes/no Subjects recorded body temperature via thermometer
Time frame: Measured daily for 90 days
Yes/no
Time frame: Measured daily for 90 days
Yes/no
Time frame: Measured daily for 90 days
Yes/no
Time frame: Measured daily for 90 days
Yes/no
Time frame: 70 days
Heart rate
Time frame: 70 days
Pulse oximetry
Time frame: 70 days
Total sleep time in hours
Time frame: 70 days
Sleep efficiency (percent of time sleeping/total amount of time in bed)
Temple University
Other
Feasibility of Using Daily Home HNHF-O2 During Sleep and/or Daytime in Hypercapnic COPD Patients Following Recent (< 12 Wks.) Hospitalization for AECOPD for 90 Days
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