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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMing Zhong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial 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%);

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Using transnasal high flow1 intervention
Group B: Use a non-invasive mask1 intervention

Trial outcomes

Primary outcomes

1

Oxygenation index

Blood gas analyzer was used for analysis after arterial extraction

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
2

Ventilation/perfusion ratio

Electrical impedance tomography

Time frame
baseline, before intervention; After inhaling 5ppm of NO for 1 hour; After inhaling 40ppm of NO for 1 hour

Secondary outcomes

Other outcomes

Sponsors and contacts

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Ming Zhong

Lead sponsor

Shanghai Zhongshan Hospital

Sponsor institution

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