Comparing oxygen therapies for patients with acute respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of three non-invasive oxygenation strategies—Continuous Positive Airway Pressure (CPAP), High-flow Nasal Oxygen (HFNO), and Non-invasive Ventilation (NIV)—in preventing intubation in patients suffering from acute hypoxemic respiratory failure. The study aims to determine which method leads to higher rates of intubation-free survival. Participants will be adults aged 18 and older who meet specific criteria related to oxygen levels and respiratory support needs. The trial will compare outcomes among the different oxygenation strategies to identify the most effective approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongda Hospital, School of Medicine, Southeast University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Ling Liu, PhD
• Email: liulingdoctor@126.com
• Phone: +8613851435472

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Protocol for weaning patients off high-flow nasal oxygen therapy in intensive care

  This study is testing a new plan to help patients in intensive care who are on high-flow nasal oxygen therapy breathe on their own again by Day 7.

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• Real-time monitoring and early warning for COPD patients on home NIV

  This observational study tests a multisensor real-time monitoring system to see if it can predict acute COPD flare-ups in adults using home noninvasive ventilation.

  Recruiting Beijing Chao Yang Hospital · Beijing · NCT07701096

• Predicting HFNC Failure in Acute Hypoxemic Respiratory Failure using Metabolomics and Clinical Data

  This study tests whether metabolomic blood profiles combined with routine clinical data can predict which adults with acute hypoxemic respiratory failure on high-flow nasal cannula will fail and need escalation of care.

  Recruiting Hospital del Mar Research Institute (IMIM) · Barcelona, Catalonia · NCT07607080

• Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

  This study tests whether allowing spontaneous breathing or using controlled ventilation is better for adults with acute hypoxemic respiratory failure who need invasive mechanical ventilation.

  Recruiting Oslo University Hospital · Oslo, Oslo · NCT07463885

• Predicting HFNO failure within 72 hours using a physiology-informed model at 30 minutes

  This study tests a model that uses Heart–lung physiology and 30-minute data to see if high-flow nasal oxygen will fail in adults with acute hypoxemic respiratory failure.

  Recruiting Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07366541

• IL-6 guided dexamethasone or tocilizumab treatment for hospitalized acute hypoxemic respiratory failure

  This study will test whether measuring IL-6 to guide early treatment with dexamethasone or tocilizumab helps adults hospitalized with new acute hypoxemic respiratory failure.

  Recruiting Phase 2 University Health Network, Toronto · Toronto, Ontario · NCT07334379

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.