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NCT Number: NCT07617298

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nitric Oxide Therapy Device

Shanghai, 200000, China

Location contact

Dang Xinya Xinya Dang, bachelor

SUB_INVESTIGATOR

Liu Kai Kai Liu, bachelor

PRINCIPAL_INVESTIGATOR

Nanjing Nuoling Biotechnology Co., Ltd Nuoling Nanjing Nuoling

CONTACT

[email protected]

025-58222737-8001

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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. -

Treatment and study plan

Inhale different doses of nitric oxide

Device

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.

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dang Xinya Dang Xinya, bachelor

CONTACT

[email protected]

+86 158 2199 3005

Liu Kai Liu Kai, bachelor

CONTACT

[email protected]

+86 135 1213 6346

Sponsors and collaborators

Lead sponsor

Ming Zhong

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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