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

Last updated: February 24, 2025
Sponsor: Southeast University, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Continuous Positive Airway Pressure (Cpap)

Treatment

Continuous Positive Airway Pressure

Non-invasive ventilation

High-flow nasal oxygen

Clinical Study ID

NCT06795971
TRIPOD Study
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age≥18 yrs;

  2. A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 of 300 mm Hgor less, or a ratio of pulse oximetry oxygen saturation (SpO2) to the FiO2 of 315 orless (SpO2≤97%) and the need for (1) noninvasive positive pressure ventilation withat 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

Exclusion Criteria:

  1. Patients that have already received Continuous positive airway pressure, Noninvasiveventilation 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 obstructivepulmonary disease.

  4. Moderate to severe cardiac insufficiency (New York Heart Association class >II orleft ventricular ejection fraction<50%) or cardiogenic pulmonary edema.

  5. Hemodynamic dysfunction, defined as vasopressor dose > 0.3 µg/kg/min ofnorepinephrine-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 hypoxemiadefined 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.

Study Design

Total Participants: 1300
Treatment Group(s): 3
Primary Treatment: Continuous Positive Airway Pressure
Phase:
Study Start date:
January 23, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Zhongda Hospital, School of Medicine, Southeast University

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

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