Actively Recruiting
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
Led by Southeast University, China · Updated on 2025-02-26
1300
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best non-invasive oxygen therapy to avoid intubation in adults with acute hypoxemic respiratory failure (AHRF), a serious condition often requiring intensive care and invasive ventilation with high mortality. This randomized clinical trial compares three oxygen strategies: continuous positive airway pressure (CPAP), high-flow nasal oxygen (HFNO), and non-invasive ventilation (NIV) to determine which improves intubation-free survival. Participants are randomly assigned to receive one of three treatments. The CPAP group receives face mask ventilation with carefully adjusted pressure and oxygen levels for at least 16 hours daily over 2 days, with breaks supported by HFNO. The HFNO group gets heated, humidified oxygen through nasal prongs continuously for at least 2 days. The NIV group receives face mask non-invasive ventilation combining pressure support and oxygen for at least 16 hours daily over 2 days, alternating with HFNO between sessions. During the study, researchers monitor survival without intubation over 28 days as the main outcome. They also assess mortality rates, intubation rates, discomfort levels, ventilator-free days, and hospital stay lengths. Patients are closely evaluated from randomization through hospital discharge, with data collected up to 60 days to understand treatment effects and safety. Participation lasts through these follow-up periods to capture important clinical outcomes.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute hypoxemic respiratory failure with PaO2/FiO2 ratio of 300 mm Hg or less, or SpO2/FiO2 ratio of 315 or less (with SpO2 ≥97%)
- Need for noninvasive positive pressure ventilation with at least 5 cm H2O PEEP, or high-flow nasal cannula at 30L/min or higher, or standard oxygen with flow rate of at least 10 L/min
- Signed informed consent
You will not qualify if you...
- Continuous use of CPAP or noninvasive ventilation for more than 24 hours before screening
- Previous mechanical ventilation during current hospital stay
- Exacerbation of chronic lung disease such as asthma or COPD
- Moderate to severe cardiac insufficiency (NYHA class >II or left ventricular ejection fraction <50%) or cardiogenic pulmonary edema
- Hemodynamic instability requiring high-dose vasopressors
- Impaired consciousness (Glasgow coma score ≤12)
- Urgent need for intubation due to respiratory or cardiac arrest, severe hypoxemia despite maximal oxygen
- Contraindications to noninvasive ventilation such as patient refusal, cardiorespiratory arrest, coma, non-drained pneumothorax, unresolved vomiting, airway obstruction, severe facial trauma, or recent thoracic/abdominal surgery
- Do-not-intubate order at inclusion
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 2 calendar days
Participants receive one of three respiratory support interventions: continuous positive airway pressure, high-flow nasal oxygen, or non-invasive ventilation to manage acute hypoxemic respiratory failure.
Continuous treatment sessions with required minimum daily durations as per assigned intervention
Duration - Up to 28 days
Participants are monitored for outcomes including intubation-free survival, mortality, and other clinical measures up to 28 days after randomization.
Regular assessments during the 28-day follow-up period
Trial Site Locations
Total: 1 location
1
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
L
Ling Liu, PhD
Y
Yi Yang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here