myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial

Summary

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.

Description

Eligibility

Age range

30+ years

Sex

All

Healthy volunteers

No

Interventions

• Device
  myAirvo3

  For patients assigned to the HFNT intervention group, a myAirvo 3 device will be provided. The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.

• Device
  Pulse oximeter

  A pulse oximeter will be provided to measure heart rate and pulse oximetry; subjects will enter and transmit the data on the smartphone once daily before 11AM. Heart rate and pulse oximetry measures will be taken after wearing the device for approximately 2 minutes.

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