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
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official 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
- Partial pressure of arterial oxygen to FiO2 ratio of 300 mm Hg or less, or pulse oximetry oxygen saturation to FiO2 ratio of 315 or less (SpO2 6gt;=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 at 10 L/min or more
- Signed informed consent
You will not qualify if you...
- Continuous use of CPAP or NIV for more than 24 hours before screening
- Previous mechanical ventilation during current hospitalization
- Exacerbation of chronic lung diseases such as asthma or COPD
- Moderate to severe heart failure (New York Heart Association class >II) or cardiogenic pulmonary edema
- Hemodynamic dysfunction requiring high-dose vasopressors
- Impaired consciousness with Glasgow coma score of 12 or less
- Urgent need for intubation including respiratory or cardiac arrest, severe hypoxemia despite maximal oxygen support
- Contraindications to NIV such as patient refusal, cardiorespiratory arrest, coma, pneumothorax, unresolved vomiting, airway obstruction, severe facial trauma, recent thoracic or abdominal surgery
- Do-not-intubate order at time of inclusion
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Y
Yi Yang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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