Acute Respiratory Failure (ARF)NCT07892001
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
A study testing Modified iNO in people with Acute Respiratory Failure (ARF) and Nitric Oxide, run by Southeast University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Acute Respiratory Failure (ARF), Nitric Oxide, Pneumonia
- What is being tested?
- Modified iNO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 20 Feb 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Acute respiratory failure (PaO₂/FiO₂ ratio < 300 mmHg).
- Endotracheal intubation due to pneumonia.
- Duration of mechanical ventilation ≤ 72 h.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
Chenhao Xuan, PHD, +86 83262550, xchdoctor@126.com
About this study
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
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
- Being tested
- Modified iNO
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified iNODevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Modified iNO |
| Low PEEP-FiO2 table group | No intervention | PEEP will be set according to the low FiO2-PEEP table. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days at day 28
Measured: From randomization to 28 days
Secondary outcomes (8)
28-day mortality
Measured: From randomization to 28 days
ICU days at day 28
Measured: From randomization to 28 days
Hospital days at day 28
Measured: From randomization to 28 days
Vasopressor-free days at day 28
Measured: From randomization to 28 days
Renal replacement therapy-free days at day 28
Measured: From randomization to 28 days
Change in PaO₂/FiO₂ ratio
Measured: Within 72 h of randomization
Successful weaning from mechanical ventilation
Measured: From randomization to 28 days
Proportion of patients meeting criteria for ECMO initiation
Measured: From randomization to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion20 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure (ARF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892001
- Sponsor's protocol ID
- MINO-VENT
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided