Home High-Flow Nasal Cannula vs. Noninvasive Ventilation for Stable Chronic Respiratory Failure
NCT06872801 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2025-03-12
Summary
The goal of this clinical trial is to compare the effects of home high-flow nasal cannula (HFNC) therapy and noninvasive ventilation (NIV) in patients with stable chronic hypercapnic respiratory failure. The main questions it aims to answer are:
* Does HFNC or NIV reduce blood carbon dioxide levels more effectively?
* How well do patients tolerate and adhere to each therapy?
* Are there differences in oxygen saturation, respiratory rate, and quality of life between the two treatments?
Participants Will:
* Use either HFNC (myAirvo2®) or NIV (Trilogy Evo®) every night for at least 4 hours over a 6-week period.
* Visit the hospital for checkups and arterial blood gas tests at the end of each 6-week period.
* Switch to the alternate device after six weeks as part of the crossover study design.
* Have their device usage recorded and analyzed.
Conditions
- Stable Chronic Hypercapnic Respiratory Failure
Interventions
- DEVICE
-
High-Flow Nasal Cannula
To compare the effects of NIV (Trilogy Evo®) and HFNC (myAirvo2®) in patients with chronic hypercapnic COPD.
- DEVICE
-
Noninvasive Ventilation
to compare the effects of NIV (Trilogy Evo®) and HFNC (myAirvo2®) in patients with chronic hypercapnic COPD
Sponsors & Collaborators
-
Wonju Severance Christian Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-31
- Primary Completion
- 2026-03-31
- Completion
- 2026-06-30
- FDA Device
- Yes
Countries
- South Korea
Study Locations
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