Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery

Study Overview
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Brief Summary
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Hypoxemia is a common complication after aortic surgery. As this complication has an adverse effect on the postoperative course of the patient, early treatment is important; however, the mechanism of hypoxemia after surgery for acute aortic dissection remains unclear. Recently, the investigators found that inhaled Nitric Oxide can improve the oxygenation in some of these patients. The investigators are trying to evaluate the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.

Detailed Description
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Several risk factors for severe hypoxemia after aortic surgery have been reported including advanced age, obesity, smoking history, previous heart surgery,emergency surgery,reduced cardiac function, advanced chronic obstructive pulmonary disease, excessive volume of blood transfusion,and prolonged CPB time. The routine treatment includes lung protective mechanical ventilation, recruitment maneuvers and glucocorticoids. No previous clinical studies have reported the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.

Official Title
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Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery

Conditions
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Aortic Surgery, Nitric Oxide, Hypoxemia

Intervention / Treatment
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* Drug: Inhaled Nitric Oxide
* Device: lung protective mechanical ventilation
* Device: Hemodynamic monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with refractory hypoxemia after aortic surgery; Accepting invasive mechanical ventilation; Chest X-ray and lung ultrasound to exclude the respiratory factors (eg. pulmonary edema, obstructive atelectasis, pleural effusion, pneumothorax) and hemodynamic factors (pericardial tamponade, acute pulmonary hypertension, intracardiac shunt); The ventilator parameters: PEEP>10cmH2O, VT 6-8ml/kg; The PaO2/FiO2 <= 100mmHg. Exclusion Criteria: Age <18 years old; Pregnant women; Past medical history included COPD or mental illness; The serious infection or sepsis patients; Patients with pulmonary hypertension and right ventricular dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iNO Group<br>Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions | Drug: Inhaled Nitric Oxide<br>* Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.<br>Device: lung protective mechanical ventilation<br>* Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg<br>Device: Hemodynamic monitoring<br>* Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.<br>|
| Other: Control<br>Patients are treated without iNO. | Device: lung protective mechanical ventilation<br>* Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg<br>Device: Hemodynamic monitoring<br>* Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation time (days) |  | During whole ICU stay. From date of randomization until the date of death or discharge from ICU, up to 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality |  | From date of randomization until the date of death or discharge from ICU, up to 6 months. | 
| length of hospital stay (days) |  | From date of randomization until the date of death or discharge from hospital, up to 6 months. | 
| length of ICU stay (days) |  | From date of randomization until the date of death or discharge from ICU, up to 6 months. | 
| hospital mortality |  | From date of randomization until the date of death or discharge from hospital, up to 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitric Oxide, hypoxemia, aortic surgery