An interventional study of Modified iNO in Acute Respiratory Failure (ARF), Nitric Oxide and Pneumonia, sponsored by Southeast University, China. Not yet recruiting at 1 site in China. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Southeast University, China · Not applicable, Interventional, and Treatment
Pneumonia is the main cause of ICU admission in patients with acute respiratory failure (ARF). Severe pneumonia is a serious lung infection caused by bacteria, fungi, viruses, and other pathogens. It often leads to respiratory failure requiring mechanical ventilation. It is also accompanied by septic shock or multiple organ dysfunction, and patients need intensive care. The average mortality rate is 30%-40%. Therefore, there is an urgent need to find treatments that improve outcomes in patients with severe pneumonia. Inhaled nitric oxide (iNO) can selectively dilate pulmonary vessels in well-ventilated lung areas. This reduces pulmonary artery pressure, improves the ventilation/perfusion ratio, and increases oxygenation. At 80 ppm, iNO can effectively reduce mean pulmonary artery pressure and pulmonary vascular resistance. It also reduces oxidative stress and has anti-inflammatory effects. Short-term inhalation is safe. The level of positive end-expiratory pressure (PEEP) affects the effect of NO. Setting PEEP according to airway opening pressure (AOP) can deliver iNO efficiently to target areas. Based on this, we designed this randomized controlled trial to investigate whether a modified iNO regimen, PEEP set according to AOP combined with 80 ppm NO, improves outcomes in patients with acute respiratory failure receiving mechanical ventilation.
2,072 studies on the registry are indexed under Pneumonia; 286 are open to participants now.
This study's planned enrollment of 424 is above the median of 107 across 1,263 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Southeast University, China is the lead sponsor of 165 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Patients will receive PEEP set according to AOP and undergo an iNO trial with an initial concentration of 80 ppm and subsequent stepwise reduction.
Device: Modified iNO
PEEP will be set according to the low FiO2-PEEP table.
At enrollment, AOP will be measured using the low-flow inflation technique. If AOP is present and AOP + 2 cmH₂O is greater than the PEEP set according to the low PEEP/FiO₂ table, PEEP will be set at AOP + 2 cmH₂O. After PEEP has been set, iNO will be initiated at 80 ppm, maintained for 48 h, and then reduced to 40 ppm. Gradual weaning from NO should be initiated after the P/F ratio improves.
Ventilator-free days at day 28
Time frame: From randomization to 28 days
28-day mortality
Time frame: From randomization to 28 days
ICU days at day 28
Time frame: From randomization to 28 days
Hospital days at day 28
Time frame: From randomization to 28 days
Vasopressor-free days at day 28
Time frame: From randomization to 28 days
Renal replacement therapy-free days at day 28
Time frame: From randomization to 28 days
Change in PaO₂/FiO₂ ratio
Time frame: Within 72 h of randomization
Successful weaning from mechanical ventilation
Time frame: From randomization to 28 days
Proportion of patients meeting criteria for ECMO initiation
Time frame: From randomization to 28 days
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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