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NOT YET RECRUITING
NCT07892001
NA

Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure

Sponsor: Southeast University, China

View on ClinicalTrials.gov

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.

Official title: Effect of a Modified Inhaled Nitric Oxide Regimen on Outcomes in Patients With Acute Respiratory Failure Receiving Mechanical Ventilation: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

424

Start Date

2026-11-01

Completion Date

2029-02-20

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, China