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

NCT07617298 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: B2026-187
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDS; inhaled nitric oxide

Outcome Measures

Primary Outcomes (2)

• Oxygenation index

  Blood gas analyzer was used for analysis after arterial extraction

  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

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

Study Arms (2)

Using transnasal high flow

ARDS patients using high nasal flow

Device: Inhale different doses of nitric oxide

Use a non-invasive mask

ARDS patients using non-invasive face masks

Device: Inhale different doses of nitric oxide

Interventions

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.

Using transnasal high flow

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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%);

You may qualify if:

• 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;

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Ming Zhong: lead

Study Sites (1)

Nitric Oxide Therapy Device

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Liu Kai Liu Kai, bachelor

  Fudan University

  PRINCIPAL INVESTIGATOR

• Dang Xinya Xinya Dang, bachelor

  Fudan University

  STUDY CHAIR

• Zhong Ming Ming Zhong, doctor

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Dang Xinya Dang Xinya, bachelor

CONTACT

+86 158 2199 3005; dang.xinya@zs-hospital.sh.cn

Liu Kai Liu Kai, bachelor

CONTACT

+86 135 1213 6346; Liu.kai1@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: deputy director

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2027/6/30-2028/12/30
• Access Criteria: publish a paper

Locations

CN (1)