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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Oxygenation index [Срок оценки: 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 [Срок оценки: baseline, before intervention; After inhaling 5ppm of NO for 1 hour; After inhaling 40ppm of NO for 1 hour]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;
• 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. -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Nitric Oxide Therapy Device — Шанхай

Идентификаторы

NCT: NCT07617298 · B2026-187

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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