Investigating airflow and pressure in heart failure patients using high-flow oxygen therapy and non-invasive ventilation
Using Electrical Impedance Tomography to Investigate the Relationship Between Airflow Rate During High-flow Oxygen Therapy and Pressure in Patients With Heart Failure Compared to Non-invasive Ventilation
This study is testing if high-flow oxygen therapy can help heart failure patients breathe better compared to non-invasive ventilation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06107907 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the relationship between airflow rate during high-flow oxygen therapy (HFOT) and pressure in patients with heart failure, comparing it to non-invasive ventilation (NIV). Utilizing electrical impedance tomography (EIT), the study will assess how different airflow rates affect positive end-expiratory pressure (PEEP) and other respiratory parameters. Participants will be randomly assigned to receive either HFOT or NIV in a controlled setting, with various respiratory metrics recorded throughout the intervention. The goal is to better understand the efficacy of HFOT in improving patient outcomes in heart failure cases.
Who should consider this trial
Good fit: Ideal candidates include ICU patients with heart failure who require non-invasive ventilation or high-flow oxygen therapy and have stable respiratory conditions.
Not a fit: Patients under 18 years old, those with severe COPD, or individuals with contraindications to the therapies being tested may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment options for heart failure patients by providing insights into effective respiratory support strategies.
How similar studies have performed: Previous studies have shown promising results for high-flow oxygen therapy in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients in the intensive care unit (ICU) with PaO2/FiO2 ≤ 300, requiring Non-Invasive Ventilation (NIV) and High-Flow Oxygen Therapy (HFOT) and stable use of NIV and HFOT for at least 24 hours will be eligible for enrollment. * Evidence of pulmonary infiltrates on chest X-ray in patients with heart failure. * Alert and able to follow instructions. Exclusion Criteria: * Age \< 18 years. * Patients with a history of tracheostomy. * Hemodynamically unstable (defined as a mean arterial pressure persistently below 60 mmHg despite fluid resuscitation or vasopressor support). * Severe chronic obstructive pulmonary disease (COPD). * History of nasal trauma and/or nasal septal deviation or any other reason preventing the use of High-Flow Oxygen Therapy (HFOT). * Presence of facial wounds or any other reason preventing the use of Non-Invasive Ventilation (NIV). * Contraindications to Electrical Impedance Tomography (EIT) use (e.g., patients with implanted pacemakers) or inability to place EIT belt (e.g., due to wound dressings or chest drainage).
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Ming-Hann Shin — Division of Respiratory Therapy, Department of Integrated Diagnostic and Therapeutics, National Taiwan University Hospital
- Study coordinator: Ming-Hann Shin
- Email: x106731@ntuh.gov.tw
- Phone: +886934017034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.