Comparing oxygen therapies for patients with acute respiratory failure

Effects of Face Mask Continuous Positive Airway Pressure Vs. Noninvasive Ventilation Vs. High-flow Nasal Oxygen on Intubation-free Survival in Acute Hypoxemic Respiratory Failure: the TRIPOD Randomized Clinical Trial

This study is testing which of three oxygen therapies—CPAP, high-flow nasal oxygen, or non-invasive ventilation—works best to help adults with severe breathing problems avoid needing a breathing tube.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Southeast University, China (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06795971 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of three non-invasive oxygenation strategies—Continuous Positive Airway Pressure (CPAP), High-flow Nasal Oxygen (HFNO), and Non-invasive Ventilation (NIV)—in preventing intubation in patients suffering from acute hypoxemic respiratory failure. The study aims to determine which method leads to higher rates of intubation-free survival. Participants will be adults aged 18 and older who meet specific criteria related to oxygen levels and respiratory support needs. The trial will compare outcomes among the different oxygenation strategies to identify the most effective approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older experiencing acute hypoxemic respiratory failure requiring non-invasive oxygen support.

Not a fit: Patients who have already received non-invasive ventilation for more than 24 hours or have severe chronic lung disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the need for invasive mechanical ventilation in patients with acute respiratory failure.

How similar studies have performed: Previous studies have shown that non-invasive oxygenation strategies can be effective, but this specific comparison of CPAP, HFNO, and NIV is novel.

Eligibility criteria

Inclusion Criteria:

1. Age≥18 yrs;
2. A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 of 300 mm Hg or less, or a ratio of pulse oximetry oxygen saturation (SpO2) to the FiO2 of 315 or less (SpO2≤97%) and the need for (1) noninvasive positive pressure ventilation with at least 5 cm H2O PEEP, or (2) high-flow nasal cannula at 30L/min or higher, or (3) standard oxygen with oxygen flow rate of at least 10 L/min;
3. Sign informed consent.

Exclusion Criteria:

1. Patients that have already received Continuous positive airway pressure, Noninvasive ventilation continuously for more than 24 hours before the screening visit.
2. Previous bout of mechanical ventilation during index hospitalization.
3. Exacerbation of chronic lung disease, including asthma or chronic obstructive pulmonary disease.
4. Moderate to severe cardiac insufficiency (New York Heart Association class \>II or left ventricular ejection fraction\<50%) or cardiogenic pulmonary edema.
5. Hemodynamic dysfunction, defined as vasopressor dose \> 0.3 µg/kg/min of norepinephrine-equivalent to maintain systolic blood pressure \> 90 mm Hg.
6. Impaired consciousness with a Glasgow coma score ≤ 12.
7. Patients with urgent need for intubation, including respiratory or cardiac arrest, respiratory pauses with loss of consciousness or gasping for air, severe hypoxemia defined as SpO2 lower than 90% despite maximal oxygen support.
8. Patients with contraindication to NIV according to the French consensus conference, patient refusal, cardiorespiratory arrest, coma, non-drained pneumothorax, unresolved vomiting, upper airway obstruction, hematemesis or severe facial trauma, thoracic or abdominal surgery in the previous 7 days.
9. A do-not-intubate order at time of inclusion.
10. Pregnancy.

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital, School of Medicine, Southeast University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Ling Liu, PhD

Conditions: Acute Hypoxemic Respiratory Failure, High-Flow Nasal Oxygen Therapy, Noninvasive Ventilation, Continuous Positive Airway Pressure