Clinical trial NCT06795971: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypoxemic Respiratory Failure
High-Flow Nasal Oxygen Therapy
Noninvasive Ventilation
Continuous Positive Airway Pressure (CPAP)
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

1. Age≥18 yrs;
2. 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 positive pressure ventilation with at 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 Criteria:

1. Patients that have already received Continuous positive airway pressure, Noninvasive ventilation 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 obstructive pulmonary disease.
4. Moderate to severe cardiac insufficiency (New York Heart Association class \>II or left ventricular ejection fraction\<50%) or cardiogenic pulmonary edema.
5. Hemodynamic dysfunction, defined as vasopressor dose \> 0.3 µg/kg/min of norepinephrine-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 hypoxemia defined 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.

Primary outcomes:
measure: Intubation-free survival rate
timeFrame: From randomization to 28 days
Secondary outcomes:
measure: 28-day mortality
timeFrame: From randomization to 28 days
measure: Intubation rate within 28 days
timeFrame: From randomization to 28 days
measure: A ranked composite score incorporating death and intubation through day 28
timeFrame: From randomization to 28 days
measure: Meeting the prespecified criteria for intubation within 28 days.
timeFrame: From randomization to 28 days
measure: ICU mortality
timeFrame: From randomization to ICU discharge, assessed up to 60 days
measure: In-hospital mortality
timeFrame: From randomization to hospital discharge, assessed up to 60 days
measure: Change in Discomfort scale after 1 hour of randomization
timeFrame: Time from randomization to 1hour
measure: Invasive ventilator-free days at 28 days
timeFrame: From randomization to 28 days
measure: Circulatory support-free days at day 28
timeFrame: From randomization to 28 days
measure: Time from randomization to an improvement of two points on a seven-category ordinal scale
timeFrame: From randomization to 28 days
measure: ICU-free days at day 28
timeFrame: From randomization to 28 days
measure: Hospital-free days at day 28
timeFrame: From randomization to 28 days
Other outcomes:
measure: Vomiting
timeFrame: From randomization to 28 days
measure: Aspiration of gastric contents
timeFrame: From randomization to 28 days
measure: Nasal/facial skin necrosis
timeFrame: From randomization to 28 days
measure: Pneumothorax
timeFrame: From randomization to 28 days
measure: Cardiac arrest
timeFrame: From randomization to 28 days
measure: Other adverse events
timeFrame: From randomization to 28 days
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, School of Medicine, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital, School of Medicine, Southeast University
name: Ling Liu, PhD
role: STUDY_DIRECTOR
References: