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

Southeast University, China

Status: Enrolling

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

Treatments: Device: Non-invasive ventilation; Device: Continuous Positive Airway Pressure; Device: High-flow nasal oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT06795971

TRIPOD Study

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,300 participants in 3 patient groups

Continuous Positive Airway Pressure

Experimental group

Description:

Patients will receive continuous positive airway pressure

Treatment:

Device: Continuous Positive Airway Pressure

High-flow nasal oxygen

Active Comparator group

Description:

Patients will receive high-flow nasal oxygen

Treatment:

Device: High-flow nasal oxygen

Non-invasive ventilation

Active Comparator group

Description:

Patients will receive non-invasive ventilation

Treatment:

Device: Non-invasive ventilation