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

NARecruitingINTERVENTIONAL
Enrollment

1,300

Participants

Timeline

Start Date

January 23, 2025

Primary Completion Date

October 31, 2027

Study Completion Date

December 31, 2027

Conditions
Acute Hypoxemic Respiratory FailureHigh-Flow Nasal Oxygen TherapyNoninvasive VentilationContinuous Positive Airway Pressure (CPAP)
Interventions
DEVICE

Continuous Positive Airway Pressure

"1. Patients were placed at a 45-degree supine position, and noninvasive ventilation was delivered to the patient through a face mask connected to an ICU ventilator.~2. PEEP was started at 5 cm H2O with a FiO2 of 0.5 at initiation. PEEP and FiO2 were titrated to maintain SpO2 between 94 and 98%, remaining constant for at least 5 min.~3. CPAP was initiated with a first session of at least 4 h, the minimally required duration of noninvasive ventilation was 16 hours per day for at least 2 calendar days. Between noninvasive-ventilation sessions, patients received HFNO."

DEVICE

High-flow nasal oxygen

"1. Oxygen was passed through a heated humidifier (MR850, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs, with a gas flow rate of 50 liters per minute and an FiO2 of 0.5 at initiation. HFNO heating temperature was prespecified at 37°C.~2. FiO2 will be titrated to maintain SpO2 between 94 and 98%, remaining constant for at least 5 min.~3. HFNO was applied for at least 2 calendar days."

DEVICE

Non-invasive ventilation

"1. Patients were placed at a 45-degree supine position, and noninvasive ventilation was also delivered to the patient through a face mask connected to an ICU ventilator. The mask most appropriate for the patient will be selected and adjusted to minimize leakage and pressure points.~2. The inspiratory positive airway pressure (pressure support plus PEEP) was initiated between 12 and 14 cm H2O, PEEP was started at 5 cm H2O with a FiO2 of 0.5 at initiation. FiO2 was titrated to maintain SpO2 between 94 and 98%, remaining constant for at least 5 min.~3. NIV was initiated with a first session of at least 4 h, the minimally required duration of noninvasive ventilation was 16 hours per day for at least 2 calendar days. Between noninvasive-ventilation sessions, patients received HFNO."

Trial Locations (1)

210009

RECRUITING

Zhongda Hospital, School of Medicine, Southeast University, Nanjing

All Listed Sponsors
lead

Southeast University, China

OTHER