Effect of Inhaled Nitric Oxide Therapy in Adults With Moderate-to-Severe Acute Respiratory Distress Syndrome

NCT ID: NCT07334873

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 536 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this clinical trial is to evaluate whether inhaled nitric oxide (iNO), added to standard care, can reduce mortality in adults with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). The main questions it aims to answer are:

Does iNO therapy reduce 28-day all-cause mortality compared to standard care alone? Does iNO therapy increase the number of ventilator-free days through day 28? If there is a comparison group: Researchers will compare the group receiving iNO plus standard care with the group receiving placebo plus standard care to see if iNO improves survival and other clinical outcomes.

Participants will:

Be randomly assigned to receive either iNO or a placebo through the ventilator.

Receive all other standard treatments for ARDS as per current guidelines. Be closely monitored for 28 days to track survival, time on the ventilator, and safety.

Conditions

ARDS (Moderate or Severe)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care for ARDS+Inhaled Nitric Oxide

Group Type: EXPERIMENTAL

Inhaled Nitric Oxide Therapy

Intervention Type: PROCEDURE

Patients randomized to the intervention group will receive inhaled nitric oxide (iNO) delivered via the portable INOwill N200 system in addition to standard ARDS care. iNO administration will commence immediately upon enrollment, with its concentration set and titrated in accordance with established clinical practice guidelines.

Interventions

Inhaled Nitric Oxide Therapy

Patients randomized to the intervention group will receive inhaled nitric oxide (iNO) delivered via the portable INOwill N200 system in addition to standard ARDS care. iNO administration will commence immediately upon enrollment, with its concentration set and titrated in accordance with established clinical practice guidelines.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Patients diagnosed with moderate-to-severe ARDS according to the 2023 Global (or international) criteria.

Exclusion Criteria

• Known allergy to iNO.
• Congenital methemoglobinemia.
• End-stage chronic lung disease (e.g., lung cancer, prior pneumonectomy/lung transplant).
• Shock (norepinephrine >0.5 μg/kg/min or equivalent for >6 hours) at treatment initiation.
• Pulmonary hypertension (PASP >45 mmHg by echo or mPAP ≥25 mmHg by catheterization).
• Serum creatinine >2.5 mg/dL (221 μmol/L).
• Major bleeding (e.g., intracranial, pulmonary) or platelet count <20×10⁹/L.
• Expected ICU/mechanical ventilation <24 hours.
• Pre-enrollment ECMO therapy.
• Any investigator-assessed unsuitability for the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NFEC-2025-708

Identifier Type: -

Identifier Source: org_study_id