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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03221387
Other study ID # 24406
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2017
Est. completion date December 15, 2019

Study information

Verified date May 2021
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 15, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Temple University Hospital Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Temple University Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Sputum Quantity Volume of sputum Measured daily for 90 days
Other Sputum Consistency Watery, thin, thick, none, no report made Measured daily for 90 days
Other Sputum Color Clear, yellow, brown, white, none Measured daily for 90 days
Other Peak Flow liters/minute Measured daily for 90 days
Other Body Temperature > 100 Degrees F Yes/no Subjects recorded body temperature via thermometer Measured daily for 90 days
Other Presence of Cough Yes/no Measured daily for 90 days
Other Presence of Wheeze Yes/no Measured daily for 90 days
Other Presence of Sore Throat Yes/no Measured daily for 90 days
Other Presence of Nasal Congestion Yes/no Measured daily for 90 days
Other Polysomnography Heart rate 70 days
Other Polysomnography Pulse oximetry 70 days
Other Polysomnography Total sleep time in hours 70 days
Other Polysomnography Sleep efficiency (percent of time sleeping/total amount of time in bed) 70 days
Primary 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 Spirometry Change in FEV1 90 days
Secondary Change in 6 Minute Walk Distance Total distance walked in 6 minutes 90 days
Secondary Breathlessness Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath 90 days
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