ARDS (Acute Respiratory Distress Syndrome)NCT07617298
EIT Evaluation of the Impact of Inhaled Nitric Oxide on Ventilation/Perfusion Mismatch in ARDS Patients Receiving Noninvasive Respiratory Support
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Ming Zhong at 1 site in China.
Trial summary
This study aimed to quantitatively evaluate the immediate effect of inhaled nitric oxide on the ventilation / perfusion ratio in ARDS patients receiving nasal high flow oxygen therapy or noninvasive ventilation using electrical impedance tomography. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Inhale different doses of nitric oxide
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non invasive ventilation (NIV) with PEEP or CPAP ≥ 5 cmH2O or nasal high flow oxygen therapy (hfnc) with flow rate ≥ 30 l/min met the diagnostic criteria of non intubated ARDS according to the new global definition of ARDS: pao2/fio2 ≤ 300MMHG or spo2/fio2 ≤ 315 (SpO2 ≤ 97%);
Who may be able to join
- Age ≥ 18 years, gender unlimited;
- Non invasive ventilation (NIV) with PEEP or CPAP ≥ 5 cmH2O or nasal high flow oxygen therapy (hfnc) with flow rate ≥ 30 l/min met the diagnostic criteria of non intubated ARDS according to the new global definition of ARDS: pao2/fio2 ≤ 300MMHG or spo2/fio2 ≤ 315 (SpO2 ≤ 97%);
- Patients with spontaneous breathing and clear consciousness can cooperate with instructions and hold breath for ≥ 8s;
- Patients with spontaneous breathing and clear consciousness can cooperate with instructions and hold breath for ≥ 8s;
Who cannot join
- There are signs of worsening respiratory failure requiring immediate intubation: respiratory rate > 40 times / min with severe use of auxiliary respiratory muscles or contradictory breathing, or Paco ₂ > 50 mmHg and pH < 7.25;
- Hemodynamic instability or the presence of refractory shock; That is, the vasoactive drugs increased by more than 30% within 6 hours, or the norepinephrine dose exceeded 0.5 μ g /kg/min;
- There are contraindications to EIT monitoring, such as thoracic implantable defibrillator / pacemaker, large area of severe skin damage on the chest, serious allergy to electrode patches, etc;
- There are contraindications to the use of iNO: such as severe left ventricular dysfunction, active bleeding, etc;
- Patients with intracranial hypertension, severe arrhythmia or digestive tract obstruction;
- Pneumothorax and massive pleural effusion were not treated;
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- Chronic kidney disease;
- Pregnant or lactating women;
- Participating in other studies;
- The investigator judged that there were any other circumstances not suitable for participation in this study. -
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
Nitric Oxide Therapy Device
Shanghai, 200000
Nanjing Nuoling Biotechnology Co., Ltd Nuoling Nanjing Nuoling, 025-58222737-8001, contact@novlead.com
Liu Kai Kai Liu, bachelor
About this study
Official title: EIT Evaluation of the Impact of Inhaled Nitric Oxide on Ventilation/Perfusion Mismatch in ARDS Patients Receiving Noninvasive Respiratory Support: A Prospective Physiological Study
This study aimed to quantitatively evaluate the immediate effect of inhaled nitric oxide on the ventilation / perfusion ratio in ARDS patients receiving nasal high flow oxygen therapy or noninvasive ventilation using electrical impedance tomography.
Read the detailed description
The immediate effect of different doses of iNO (5-40 ppm) on the degree of v/q mismatch in the lungs of ARDS patients receiving hfnc or NIV was quantitatively evaluated by EIT. Objective to explore the effects of different doses of iNO on oxygenation, ventilation distribution and perfusion distribution in ARDS patients using hfnc or NIV, as well as the differences and influencing factors of individual response.
- Being tested
- Inhale different doses of nitric oxide
- Keywords
- ARDS, inhaled nitric oxide
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhale different doses of nitric oxideDevice
T0 (baseline): 20 to 30 minutes after initial stabilization; T1 (iNO 5ppm 1h): The patient non invasively inhales 5ppm NO for 1h. If the reaction standard (PaO2/FiO2 improvement ≥ 20%) is met, maintain the dose until the end of the study. Otherwise, continue to double the NO concentration and proceed with the following steps:; T2 (iNO 10ppm 1h): The patient non invasively inhales 10ppm of NO for 1h. If the reaction standard is met, maintain the dose until the end of the study, otherwise continue to double the NO concentration and proceed with the following steps; T3 (iNO 20ppm 1h): The patient non invasively inhales 20ppm NO for 1h. If the reaction standard is met, maintain the dose until the end of the study, otherwise continue to double the NO concentration and proceed with the following steps; T4 (iNO 40ppm 1h): The patient non invasively inhales 40ppm NO for 1h. All subjects completed the evaluation regardless of whether they met the response criteria.
Inhale different doses of nitric oxideDevice
T0 (baseline): 20 to 30 minutes after initial stabilization; T1 (iNO 5ppm 1h): The patient non invasively inhales 5ppm NO for 1h. If the reaction standard (PaO2/FiO2 improvement ≥ 20%) is met, maintain the dose until the end of the study. Otherwise, continue to double the NO concentration and proceed with the following steps:; T2 (iNO 10ppm 1h): The patient non invasively inhales 10ppm of NO for 1h. If the reaction standard is met, maintain the dose until the end of the study, otherwise continue to double the NO concentration and proceed with the following steps; T3 (iNO 20ppm 1h): The patient non invasively inhales 20ppm NO for 1h. If the reaction standard is met, maintain the dose until the end of the study, otherwise continue to double the NO concentration and proceed with the following steps; T4 (iNO 40ppm 1h): The patient non invasively inhales 40ppm NO for 1h. All subjects completed the evaluation regardless of whether they met the response criteria.
| Study group | Role | What they receive |
|---|---|---|
| Using transnasal high flow | ARDS patients using high nasal flow Receives: Device: Inhale different doses of nitric oxide | |
| Use a non-invasive mask | ARDS patients using non-invasive face masks Receives: Device: Inhale different doses of nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index
Blood gas analyzer was used for analysis after arterial extraction
Measured: baseline, before intervention; Time point 1: After inhaling 5ppm of NO for 1 hour; Time point 2: After inhaling 10ppm of NO for 1 hour; Time point 3: After inhaling 20ppm of NO for 1 hour; Time point 4: After inhaling 40ppm of NO for 1 hour
Ventilation/perfusion ratio
Electrical impedance tomography
Measured: baseline, before intervention; After inhaling 5ppm of NO for 1 hour; After inhaling 40ppm of NO for 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming Zhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Zhong, Shanghai Zhongshan Hospital
- Investigators
- Liu Kai Liu Kai, bachelor, Principal investigator, Fudan UniversityDang Xinya Xinya Dang, bachelor, Study chair, Fudan UniversityZhong Ming Ming Zhong, doctor, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617298
- Sponsor's protocol ID
- B2026-187
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPDs collected during the trial period
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EIT Evaluation of the Impact of Inhaled Nitric Oxide on Ventilation/Perfusion Mismatch in ARDS Patients Receiving Noninvasive Respiratory Support: A Prospective Physiological Study
- ClinicalTrials.gov ID
- NCT07617298
- Acronym / sponsor ID
- B2026-187
- Keywords
- ARDS, inhaled nitric oxide
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ming ZhongUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to quantitatively evaluate the immediate effect of inhaled nitric oxide on the ventilation / perfusion ratio in ARDS patients receiving nasal high flow oxygen therapy or noninvasive ventilation using electrical impedance tomography.
Detailed description
The immediate effect of different doses of iNO (5-40 ppm) on the degree of v/q mismatch in the lungs of ARDS patients receiving hfnc or NIV was quantitatively evaluated by EIT. Objective to explore the effects of different doses of iNO on oxygenation, ventilation distribution and perfusion distribution in ARDS patients using hfnc or NIV, as well as the differences and influencing factors of individual response.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using transnasal high flow | – | Device: Inhale different doses of nitric oxideARDS patients using high nasal flow |
| Use a non-invasive mask | – | Device: Inhale different doses of nitric oxideARDS patients using non-invasive face masks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non invasive ventilation (NIV) with PEEP or CPAP ≥ 5 cmH2O or nasal high flow oxygen therapy (hfnc) with flow rate ≥ 30 l/min met the diagnostic criteria of non intubated ARDS according to the new global definition of ARDS: pao2/fio2 ≤ 300MMHG or spo2/fio2 ≤ 315 (SpO2 ≤ 97%);
Key inclusion criteria (4 listed)
- Age ≥ 18 years, gender unlimited;
- Non invasive ventilation (NIV) with PEEP or CPAP ≥ 5 cmH2O or nasal high flow oxygen therapy (hfnc) with flow rate ≥ 30 l/min met the diagnostic criteria of non intubated ARDS according to the new global definition of ARDS: pao2/fio2 ≤ 300MMHG or spo2/fio2 ≤ 315 (SpO2 ≤ 97%);
- Patients with spontaneous breathing and clear consciousness can cooperate with instructions and hold breath for ≥ 8s;
- Patients with spontaneous breathing and clear consciousness can cooperate with instructions and hold breath for ≥ 8s;
Key exclusion criteria (10 listed)
- There are signs of worsening respiratory failure requiring immediate intubation: respiratory rate > 40 times / min with severe use of auxiliary respiratory muscles or contradictory breathing, or Paco ₂ > 50 mmHg and pH < 7.25;
- Hemodynamic instability or the presence of refractory shock; That is, the vasoactive drugs increased by more than 30% within 6 hours, or the norepinephrine dose exceeded 0.5 μ g /kg/min;
- There are contraindications to EIT monitoring, such as thoracic implantable defibrillator / pacemaker, large area of severe skin damage on the chest, serious allergy to electrode patches, etc;
- There are contraindications to the use of iNO: such as severe left ventricular dysfunction, active bleeding, etc;
- Patients with intracranial hypertension, severe arrhythmia or digestive tract obstruction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhale different doses of nitric oxideT0 (baseline): 20 to 30 minutes after initial stabilization; T1 (iNO 5ppm 1h): The patient non invasively inhales 5ppm NO for 1h. If the reaction standard (PaO2/FiO2 improvement ≥ 20%) is met, maintain the dose until the end of the study. Otherwise, continue to double the NO concentration and proceed with the following steps:; T2 (iNO 10ppm 1h): The patient non invasively inhales 10ppm of NO for 1h. If the reaction standard is met, maintain the dose until the end of the study, otherwise continue to double the NO concentration and proceed with the following steps; T3 (iNO 20ppm 1h): The patient non invasively inhales 20ppm NO for 1h. If the reaction standard is met, maintain the dose until the end of the study, otherwise continue to double the NO concentration and proceed with the following steps; T4 (iNO 40ppm 1h): The patient non invasively inhales 40ppm NO for 1h. All subjects completed the evaluation regardless of whether they met the response criteria. | Device | Using transnasal high flow |
| Inhale different doses of nitric oxideT0 (baseline): 20 to 30 minutes after initial stabilization; T1 (iNO 5ppm 1h): The patient non invasively inhales 5ppm NO for 1h. If the reaction standard (PaO2/FiO2 improvement ≥ 20%) is met, maintain the dose until the end of the study. Otherwise, continue to double the NO concentration and proceed with the following steps:; T2 (iNO 10ppm 1h): The patient non invasively inhales 10ppm of NO for 1h. If the reaction standard is met, maintain the dose until the end of the study, otherwise continue to double the NO concentration and proceed with the following steps; T3 (iNO 20ppm 1h): The patient non invasively inhales 20ppm NO for 1h. If the reaction standard is met, maintain the dose until the end of the study, otherwise continue to double the NO concentration and proceed with the following steps; T4 (iNO 40ppm 1h): The patient non invasively inhales 40ppm NO for 1h. All subjects completed the evaluation regardless of whether they met the response criteria. | Device | Use a non-invasive mask |
Primary outcome
Oxygenation index
Time frame: baseline, before intervention; Time point 1: After inhaling 5ppm of NO for 1 hour; Time point 2: After inhaling 10ppm of NO for 1 hour; Time point 3: After inhaling 20ppm of NO for 1 hour; Time point 4: After inhaling 40ppm of NO for 1 hour
Blood gas analyzer was used for analysis after arterial extraction
Ventilation/perfusion ratio
Time frame: baseline, before intervention; After inhaling 5ppm of NO for 1 hour; After inhaling 40ppm of NO for 1 hour
Electrical impedance tomography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Yes. All IPDs collected during the trial period
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liu Kai Liu Kai, bachelor principal investigator
Fudan University
Dang Xinya Xinya Dang, bachelor study chair
Fudan University
Zhong Ming Ming Zhong, doctor study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Ming Zhong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dang Xinya Dang Xinya, bachelor (+86 158 2199 3005, dang.xinya@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation index (time frame: baseline, before intervention; Time point 1: After inhaling 5ppm of NO for 1 hour; Time point 2: After inhaling 10ppm of NO for 1 hour; Time point 3: After inhaling 20ppm of NO for 1 hour; Time point 4: After inhaling 40ppm of NO for 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.