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Clinical Trials in China / NCT07892001
Starting soon Not applicable

Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure

NCT07892001 · tracked via the Priya Life Science China tracker
Sponsor
Southeast University, China
Phase
Not applicable
Started
2026-11-01
Last updated
2026-10-27

Condition(s) studied

Acute Respiratory Failure (ARF)Nitric OxidePneumonia

Investigational drug(s) / intervention(s)

Modified iNO

Modified iNO: 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.

Study summary

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, the study team 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years. 2. Acute respiratory failure (PaO₂/FiO₂ ratio \< 300 mmHg). 3. Endotracheal intubation due to pneumonia. 4. Duration of mechanical ventilation ≤ 72 h. Exclusion Criteria: 1. Expected duration of mechanical ventilation \< 48 h. 2. Severe chronic respiratory disease requiring long-term home oxygen therapy or noninvasive ventilation. 3. Severe other organs dysfunction with a low expected survival (7 days) or palliative care. 4. History of pulmonary malignancy, pneumonectomy, or lung transplantation. 5. Patients who received iNO or ECMO prior to enrollment. 6. Pregnancy or lactation. 7. Refusal to sign the informed consent.

Primary outcome measure(s)

  • Ventilator-free days at day 28 — From randomization to 28 days

Trial sites (1)

FacilityCityRegionStatus
Zhongda Hospital, School of Medicine, Southeast University Nanjing Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07892001 on ClinicalTrials.gov ↗ ← All trials in China