Advanced Bedside Lung Imaging and Respiratory Muscle Monitoring for Respiratory Support Management in Chronically Ill Patients With Acute Respiratory Failure: From Hospital to Home
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 16
- Primary Endpoint
- dyspnea modification
Study Overview
Brief Summary
This study is testing whether a new type of home oxygen therapy, called high-flow nasal cannula (HFNC), can improve breathing comfort and quality of life for people with long-term lung or heart conditions who need oxygen after leaving the hospital.
HFNC delivers warm, humidified oxygen at higher flow rates than standard oxygen therapy, which may reduce shortness of breath, improve sleep, and make daily activities easier. The therapy will be provided using the myAirvo™3 device, which also allows doctors to check patients' oxygen levels, heart rate, and symptoms remotely. All patients will also wear a small device (RootiREX) to monitor heart rhythm, sleep quality, and detect breathing pauses at night.
Participants will try both treatments - HFNC and standard oxygen therapy - for short periods, in random order, so that researchers can directly compare the effects within the same patient. Each treatment period will last two weeks, with a short break in between.
The main goal of the study is to see whether HFNC reduces shortness of breath (measured by the modified Medical Research Council scale). Other outcomes include comfort, sleep quality, quality of life, oxygen levels, and how well patients are able to use the devices at home.
The study will last six weeks in total for each participant. Researchers expect that HFNC will improve breathing comfort, stabilize oxygen levels, and reduce the need for hospital visits during this time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (≥18 years) with chronic respiratory (e.g., COPD, interstitial lung disease) and/or cardiac disease (e.g., heart failure), Clinical indication for long-term oxygen therapy, Capability to manage home-based devices independently or with caregiver assistance Signed informed consent
Exclusion Criteria
- •Life expectancy < 3 months Inability to comply with home follow-up procedures.
Arms & Interventions
High flow nasal cannulae treatment
Participants assigned to this arm will receive home-based high-flow nasal cannula (HFNC) oxygen therapy using the myAirvo™3 device. The device delivers warm, humidified air with supplemental oxygen at a flow rate of ≥30 liters per minute, set at 37°C. Oxygen will be adjusted to maintain blood oxygen saturation (SpO₂) at or above 92%.
• Group HFNC will receive HFNC during weeks 1-2, followed by a 2-day washout period, then low-flow oxygen during weeks 3-4, followed by a second 2-day washout period, and will resume HFNC during weeks 5-6
Intervention: High-Flow Nasal Cannula (HFNC) Oxygen Therapy (Device)
Oxygen low therapy
Participants assigned to this arm will receive standard long-term oxygen therapy delivered by a conventional low-flow oxygen device. Oxygen will be titrated to maintain blood oxygen saturation (SpO₂) at or above 92%. • Group low flow oxygen will receive low-flow oxygen during weeks 1-2, followed by a 2-day washout period, then HFNC during weeks 3-4, followed by a second 2-day washout period, and will resume low-flow oxygen during weeks 5-6.
Intervention: High-Flow Nasal Cannula (HFNC) Oxygen Therapy (Device)
Oxygen low therapy
Participants assigned to this arm will receive standard long-term oxygen therapy delivered by a conventional low-flow oxygen device. Oxygen will be titrated to maintain blood oxygen saturation (SpO₂) at or above 92%. • Group low flow oxygen will receive low-flow oxygen during weeks 1-2, followed by a 2-day washout period, then HFNC during weeks 3-4, followed by a second 2-day washout period, and will resume low-flow oxygen during weeks 5-6.
Intervention: Oxygen therapy (Device)
High flow nasal cannulae treatment
Participants assigned to this arm will receive home-based high-flow nasal cannula (HFNC) oxygen therapy using the myAirvo™3 device. The device delivers warm, humidified air with supplemental oxygen at a flow rate of ≥30 liters per minute, set at 37°C. Oxygen will be adjusted to maintain blood oxygen saturation (SpO₂) at or above 92%.
• Group HFNC will receive HFNC during weeks 1-2, followed by a 2-day washout period, then low-flow oxygen during weeks 3-4, followed by a second 2-day washout period, and will resume HFNC during weeks 5-6
Intervention: Oxygen therapy (Device)
Outcomes
Primary Outcomes
dyspnea modification
Time Frame: Change from the enrollment in the study to 6 weeks
Change from the enrollment in the study to 6 weeks in dyspnea level measured by the modified Medical Research Council (mMRC) scale
Secondary Outcomes
No secondary outcomes reported
Investigators
Savino Spadaro
Professor
Università degli Studi di Ferrara