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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221387
• Other study ID #: 24406
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Hypercapnia
• Hypoxia
• Pulmonary Disease, Chronic Obstructive

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