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

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT06795971

Run by

Southeast University, China

People needed

1300

Starts

2025-01-23

Expected to finish

2027-12-31

Last updated by the study team

2025-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age≥18 yrs;
• 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;
• Sign informed consent.

You may not qualify if…

• Patients that have already received Continuous positive airway pressure, Noninvasive ventilation continuously for more than 24 hours before the screening visit.
• Previous bout of mechanical ventilation during index hospitalization.
• Exacerbation of chronic lung disease, including asthma or chronic obstructive pulmonary disease.
• Moderate to severe cardiac insufficiency (New York Heart Association class >II or left ventricular ejection fraction<50%) or cardiogenic pulmonary edema.
• Hemodynamic dysfunction, defined as vasopressor dose > 0.3 µg/kg/min of norepinephrine-equivalent to maintain systolic blood pressure > 90 mm Hg.
• Impaired consciousness with a Glasgow coma score ≤ 12.
• 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.
• 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.
• A do-not-intubate order at time of inclusion.
• Pregnancy.

Where it is running

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

Full record on ClinicalTrials.gov

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