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

Shanghai Zhongshan Hospital60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Nitric Oxide Hypoxemia

Interventions

Inhaled Nitric OxideDRUG

Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.

lung protective mechanical ventilationDEVICE

Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg

Hemodynamic monitoringDEVICE

Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients with refractory hypoxemia after aortic surgery; 2. Accepting invasive mechanical ventilation; 3. 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); 4. The ventilator parameters: PEEP\>10cmH2O, VT 6-8ml/kg; 5. The PaO2/FiO2 \<= 100mmHg. Exclusion Criteria: 1. Age \<18 years old; 2. Pregnant women; 3. Past medical history included COPD or mental illness; 4. The serious infection or sepsis patients; 5. Patients with pulmonary hypertension and right ventricular dysfunction

Outcomes

Primary Outcomes

Mechanical ventilation time (days)

Time frame: During whole ICU stay. From date of randomization until the date of death or discharge from ICU, up to 6 months.

Secondary Outcomes

ICU mortality

Time frame: From date of randomization until the date of death or discharge from ICU, up to 6 months.

length of hospital stay (days)

Time frame: From date of randomization until the date of death or discharge from hospital, up to 6 months.

length of ICU stay (days)