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

24. mai 2026 oppdatert av: Ming Zhong

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

40

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
      • Shanghai, Kina, 200000
        • Nitric Oxide Therapy Device
        • Ta kontakt med:
          • Nanjing Nuoling Biotechnology Co., Ltd Nuoling Nanjing Nuoling
          • Telefonnummer: 025-58222737-8001
          • E-post: contact@novlead.com
        • Hovedetterforsker:
          • Liu Kai Kai Liu, bachelor
        • Underetterforsker:
          • Dang Xinya Xinya Dang, bachelor

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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%);

Beskrivelse

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. -

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Using transnasal high flow
ARDS patients using high nasal flow
Enhet: 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.
Use a non-invasive mask
ARDS patients using non-invasive face masks
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oxygenation index
Tidsramme: 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
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
Tidsramme: baseline, before intervention; After inhaling 5ppm of NO for 1 hour; After inhaling 40ppm of NO for 1 hour
Electrical impedance tomography
baseline, before intervention; After inhaling 5ppm of NO for 1 hour; After inhaling 40ppm of NO for 1 hour

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ming Zhong

Etterforskere

  • Hovedetterforsker: Liu Kai Liu Kai, bachelor, Fudan University
  • Studiestol: Dang Xinya Xinya Dang, bachelor, Fudan University
  • Studieleder: Zhong Ming Ming Zhong, doctor, Fudan University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. juni 2026

Primær fullføring (Antatt)

30. desember 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

24. mai 2026

Først lagt ut (Faktiske)

1. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • B2026-187

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

All IPDs collected during the trial period

IPD-delingstidsramme

2027/6/30-2028/12/30

Tilgangskriterier for IPD-deling

publish a paper

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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