Effects of Inhaled Nitric Oxide on Sublingual Microcirculation in Patients With Right Ventricular Dysfunction After Cardiac Surgery
Effects of Inhaled Nitric Oxide on Sublingual Microcirculation in Patients With Right Ventricular Dysfunction After Cardiac Surgery: a Prospective Interventional Study
Right ventricular (RV) dysfunction complicates 0.1-3% of cardiac surgical procedures and is strongly associated with elevated postoperative mortality. Pulmonary hypertension is a key determinant of perioperative RV failure. Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator that reduces pulmonary arterial pressure and has been widely used as adjunctive therapy in this setting. However, whether iNO influences systemic microcirculatory perfusion in these patients remains undefined.
We conducted a single-centre, prospective, interventional study. Adult patients with post-cardiotomy RV dysfunction - defined as central venous pressure (CVP) ≥ 15 mmHg combined with a pulmonary artery systolic pressure (PASP) > 35 mmHg on transthoracic echocardiography - were eligible. On top of standard postoperative care, patients received inhaled NO at 10-20 ppm for 2 hours without any concomitant change in vasoactive support. General characteristics, haemodynamic variables and sublingual microcirculatory parameters were recorded at baseline and again after 2 hours of iNO. The primary endpoint was the change in sublingual perfused vessel density (PVD). Secondary endpoints included mean arterial pressure (MAP), CVP, transthoracic echocardiographic indices, oxygenation index (OI), other sublingual microcirculatory parameters, capillary refill time (CRT), duration of mechanical ventilation and ICU length of stay.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Jiangsu
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Nanjing, Jiangsu, Čína, 210009
- Zhongda Hospital, School of Medicine, Southeast University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion criteria :
- Adult patients (≥ 18 years) admitted to the ICU after cardiac surgery;
- Receiving mechanical ventilation;
- Central venous pressure (CVP) ≥ 15 mmHg plus a pulmonary artery systolic pressure (PASP) > 35 mmHg on transthoracic echocardiography;
Exclusion criteria :
- Contraindications to inhaled nitric oxide therapy, such as lethal congenital cardiac defects (including left-to-right shunts) and congenital methaemoglobinaemia;
- Known allergy or hypersensitivity to nitric oxide;
- Inability to obtain or adequately analyse sublingual microcirculatory images (e.g., due to poor image quality, motion artefact, or inability to cooperate with the acquisition protocol);
- Use of mechanical circulatory support devices that significantly influence haemodynamics, including extracorporeal membrane oxygenation (ECMO), intra-aortic balloon pump (IABP), or left ventricular assist device (LVAD);
- Age > 80 years;
- Any condition judged unsuitable for inhaled nitric oxide therapy by the treating investigator.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Experimental: Inhaled Nitric Oxide
On top of standard postoperative management (including conventional mechanical ventilation, sedation, vasoactive and inotropic support, fluid management and renal replacement therapy as clinically indicated), patients received inhaled nitric oxide at a concentration of 10-20 ppm delivered through the inspiratory limb of the ventilator circuit using a validated NO delivery system with continuous monitoring of NO, NO2 and O2 concentrations. |
On top of standard postoperative management (including conventional mechanical ventilation, sedation, vasoactive and inotropic support, fluid management and renal replacement therapy as clinically indicated), patients received inhaled nitric oxide at a concentration of 10-20 ppm delivered through the inspiratory limb of the ventilator circuit using a validated NO delivery system with continuous monitoring of NO, NO2 and O2 concentrations. The dose was titrated within this range by the treating intensivist according to the haemodynamic response. No changes to vasoactive, inotropic or vasopressor therapy, sedation or ventilator settings were made during the 2-hour study window unless clinically mandated, in which case the patient was withdrawn from analysis. Haemodynamic, echocardiographic and microcirculatory measurements were performed immediately before iNO initiation (0 h) and after 2 hours of continuous administration (2 h). |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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perfused vessel density (PVD)
Časové okno: At enrollment and 2 hours after study drug administration
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Perfused vessel density (PVD) is defined as the density of small vessels with actual blood flow per unit tissue area (usually capillaries and small vessels with diameter <20 μm), obtained noninvasively at the sublingual mucosa using a handheld vital microscope (sidestream dark field, SDF, or incident dark field, IDF) probe. |
At enrollment and 2 hours after study drug administration
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Heart rate
Časové okno: At enrollment and 2 hours after study drug administration
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At enrollment and 2 hours after study drug administration
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Mean arterial pressure
Časové okno: At enrollment and 2 hours after study drug administration
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At enrollment and 2 hours after study drug administration
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Central venous pressure
Časové okno: At enrollment and 2 hours after study drug administration
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At enrollment and 2 hours after study drug administration
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Urine output
Časové okno: At enrollment and 2 hours after study drug administration
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At enrollment and 2 hours after study drug administration
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Duration of mechanical ventilation, ICU length of stay and 28-day mortality.
Časové okno: At enrollment and 28 days after study drug administration
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At enrollment and 28 days after study drug administration
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Tricuspid annular plane systolic excursion (TAPSE)
Časové okno: At enrollment and 28 days after study drug administration
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Measures the longitudinal displacement of the tricuspid annulus toward the cardiac apex during systole, obtained by M-mode in the apical 4-chamber view. |
At enrollment and 28 days after study drug administration
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Right ventricular fractional area change (RVFAC)
Časové okno: At enrollment and 28 days after study drug administration
|
Calculated as: (RV end-diastolic area - RV end-systolic area) / RV end-diastolic area × 100%, by tracing the RV area in the apical 4-chamber view. |
At enrollment and 28 days after study drug administration
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E/e' ratio
Časové okno: At enrollment and 2 hours after study drug administration
|
This ratio is used to estimate left ventricular filling pressure (LVFP/LVEDP) and grade diastolic dysfunction. |
At enrollment and 2 hours after study drug administration
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Pulmonary artery systolic pressure (PASP)
Časové okno: At enrollment and 2 hours after study drug administration
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Noninvasively estimated from the peak tricuspid regurgitation (TR) jet velocity: PASP = 4 × (TR velocity)² + estimated right atrial pressure. |
At enrollment and 2 hours after study drug administration
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PaO₂/FiO₂ ratio
Časové okno: At enrollment and 2 hours after study drug administration
|
Arterial oxygen partial pressure divided by the fraction of inspired oxygen |
At enrollment and 2 hours after study drug administration
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Lactate
Časové okno: At enrollment and 2 hours after study drug administration
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At enrollment and 2 hours after study drug administration
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Central venous-to-arterial PCO₂ difference (Pcv-aCO₂)
Časové okno: At enrollment and 2 hours after study drug administration
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Reflects the adequacy of blood flow (cardiac output) to clear CO₂ produced by tissues-a "flow" marker rather than an oxygenation marker. |
At enrollment and 2 hours after study drug administration
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Central venous oxygen saturation (ScvO₂)
Časové okno: At enrollment and 2 hours after study drug administration
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Oxygen saturation of blood sampled from the superior vena cava (central venous catheter), reflecting the balance between systemic oxygen delivery (DO₂) and consumption (VO₂). |
At enrollment and 2 hours after study drug administration
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Capillary refill time (CRT)
Časové okno: At enrollment and 2 hours after study drug administration
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Time for distal capillary bed (e.g., fingertip/knee) to return to baseline color after standardized compression (5 s) - a bedside peripheral/ microcirculatory perfusion marker. |
At enrollment and 2 hours after study drug administration
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microvascular flow index (MFI)
Časové okno: At enrollment and 2 hours after study drug administration
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A semi-quantitative flow velocity score: the image is divided into 4 quadrants, and the predominant flow type in each quadrant is scored: 0 = no flow
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At enrollment and 2 hours after study drug administration
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proportion of perfused vessels (PPV)
Časové okno: At enrollment and 2 hours after study drug administration
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The percentage of vessels with blood flow out of all vessels: PPV = (number of perfused vessels ÷ total number of vessels) × 100% |
At enrollment and 2 hours after study drug administration
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Srdeční choroba
- Nemoci dýchacích cest
- Plicní onemocnění
- Ventrikulární dysfunkce
- Hypertenze
- Hypertenze, plicní
- Komorová dysfunkce, vpravo
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Nukleové kyseliny, nukleotidy a nukleosidy
- Puriny
- Nukleosidy
- Ribonukleosidy
- Purinové nukleosidy
- Inosin
Další identifikační čísla studie
- 2025ZDSYLL092-P01
Plán pro data jednotlivých účastníků (IPD)
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- CSR
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