Effect of Inhaled Nitric Oxide Therapy in Adults With Moderate-to-Severe Acute Respiratory Distress Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inhaled Nitric Oxide Therapy.
- Who it may be relevant to
- Registry conditions: ARDS (Moderate or Severe). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Efficacy of Inhaled Nitric Oxide Therapy in Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Trial (ENARCT-ARDS)
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- 28-day mortality [Time frame: within 28 days after randomization]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Nanfang Hospital, Southern Medical University — Guangzhou
Identifiers
NCT: NCT07334873 · NFEC-2025-708