Aortic Surgery, Hypoxemia, Nitric Oxide
Conditions
Keywords
Nitric Oxide, hypoxemia, aortic surgery
Brief summary
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
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.
Interventions
DRUGInhaled Nitric Oxide
Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.
DEVICElung protective mechanical ventilation
Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
DEVICEHemodynamic monitoring
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Countries
China
Contacts
Primary ContactGuo-wei Tu, MD
Backup ContactGuo-guang Ma, MD
Outcome results
None listed