NCT06795971 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
| NCT ID | NCT06795971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Southeast University, China |
| Condition | Acute Hypoxemic Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,300 participants in total. It began in 2025-01-23 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Acute hypoxemic respiratory failure (AHRF) is a common indication for admission to an intensive care unit (ICU), with mortality exceeding 50% in cases where invasive mechanical ventilation is needed. Therefore, assessment of the most adequate oxygen strategy to avoid intubation in patients with AHRF deserves consideration.Previous studies have indicated that non-invasive oxygenation strategies, including high-flow nasal oxygen (HFNO), helmet or face mask noninvasive ventilation (NIV), and continuous positive airway pressure (CPAP), are effective in preventing endotracheal intubation in adult patients with AHRF when compared to the standard oxygen therapy. However, the optimal non-invasive oxygenation strategies remain uncertain. This study aim to determine whether CPAP, compared with HFNC or NIV, increase the intubation-free survival during study period in patients with AHRF.
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.
Contact & Investigator
Ling Liu, PhD
STUDY DIRECTOR
Zhongda Hospital, School of Medicine, Southeast University
Frequently Asked Questions
Who can join the NCT06795971 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Hypoxemic Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06795971 currently recruiting?
Yes, NCT06795971 is actively recruiting participants. Contact the research team at liulingdoctor@126.com for enrollment information.
Where is the NCT06795971 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06795971 clinical trial?
NCT06795971 is sponsored by Southeast University, China. The principal investigator is Ling Liu, PhD at Zhongda Hospital, School of Medicine, Southeast University. The trial plans to enroll 1,300 participants.