NCT03009643

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nitric Oxide
• Hypoxemia
• Aortic Surgery

Interventions

Type	Name	Description
DRUG	Inhaled Nitric Oxide	Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.
DEVICE	lung protective mechanical ventilation	Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
DEVICE	Hemodynamic monitoring	Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2019-12-01
• First posted: 2017-01-04
• Last updated: 2018-02-05

Locations

1 site across 1 country: China