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New treatment option for Acute Hypoxemic Respiratory Failure
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
ClinicalTrials.gov ID: NCT06795971
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Sign informed consent.
You likely can't join if
- Patients that have already received Continuous positive airway pressure, Noninvasive ventilation continuously for more than 24 hours before the...
- 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...
- 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.
See the full eligibility criteria
- 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...
- Sign informed consent.
- 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...
- 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...
- A do-not-intubate order at time of inclusion.
- Pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.