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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Using transnasal high flow | ARDS patients using high nasal flow |
| |
| Use a non-invasive mask | ARDS patients using non-invasive face masks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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%);
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Liu Kai Liu Kai, bachelor | Fudan University | Principal Investigator |
| Dang Xinya Xinya Dang, bachelor | Fudan University | Study Chair |
| Zhong Ming Ming Zhong, doctor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nitric Oxide Therapy Device | Shanghai | 200000 | China |
All IPDs collected during the trial period
2027/6/30-2028/12/30
publish a paper
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| 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. |
|
| Fudan University |
| Study Director |
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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