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Clinical Trials in China / NCT07617298
Starting soon Observational

EIT Evaluation of the Impact of Inhaled Nitric Oxide on Ventilation/Perfusion Mismatch in ARDS Patients Receiving Noninvasive Respiratory Support

NCT07617298 · tracked via the Priya Life Science China tracker
Sponsor
Ming Zhong
Phase
Observational
Started
2026-06-30
Last updated
2026-06-01

Condition(s) studied

ARDS (Acute Respiratory Distress Syndrome)

Investigational drug(s) / intervention(s)

Inhale different doses of nitric oxideInhale different doses of nitric oxide

Inhale different doses of nitric oxide: 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 oxide: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years, gender unlimited; 2. 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%); 3. Patients with spontaneous breathing and clear consciousness can cooperate with instructions and hold breath for ≥ 8s; 4. Patients with spontaneous breathing and clear consciousness can cooperate with instructions and hold breath for ≥ 8s; Exclusion Criteria: 1. 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; 2. 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; 3. 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; 4. There are contraindications to the use of iNO: such as severe left ventricular dysfunction, active bleeding, etc; 5. Patients with intracranial hypertension, severe arrhythmia or digestive tract obstruction; 6. Pneumothorax and massive pleural effusion were not treated; 7. Chronic kidney disease; 8. Pregnant or lactating women; 9. Participating in other studies; 10. The investigator judged that there were any other circumstances not suitable for participation in this study. -

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nitric Oxide Therapy Device Shanghai China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07617298 on ClinicalTrials.gov ↗ ← All trials in China