Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure

NCT07892001 | Not Yet Recruiting DMC

• 1 other identifier: MINO-VENT
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Acute Respiratory Failure (ARF); Nitric Oxide; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days at day 28

  From randomization to 28 days

Secondary Outcomes (8)

• 28-day mortality

  From randomization to 28 days

• ICU days at day 28

  From randomization to 28 days

• Hospital days at day 28

  From randomization to 28 days

• Vasopressor-free days at day 28

  From randomization to 28 days

• Renal replacement therapy-free days at day 28

  From randomization to 28 days

Study Arms (2)

Modified iNO group

EXPERIMENTAL

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

Low PEEP-FiO2 table group

NO INTERVENTION

PEEP will be set according to the low FiO2-PEEP table.

Interventions

Modified iNO DEVICE

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.

Modified iNO group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Acute respiratory failure (PaO₂/FiO₂ ratio \< 300 mmHg).
• Endotracheal intubation due to pneumonia.
• Duration of mechanical ventilation ≤ 72 h.

You may not qualify if:

• Expected duration of mechanical ventilation \< 48 h.
• Severe chronic respiratory disease requiring long-term home oxygen therapy or noninvasive ventilation.
• Severe other organs dysfunction with a low expected survival (7 days) or palliative care.
• History of pulmonary malignancy, pneumonectomy, or lung transplantation.
• Patients who received iNO or ECMO prior to enrollment.
• Pregnancy or lactation.
• Refusal to sign the informed consent.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Chenhao Xuan, PHD

CONTACT

+86 83262550; xchdoctor@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pH.D

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 20, 2029
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

CN (1)